U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dose calculation accuracy may in some situations be less than expected. the user must be aware in order to avoid incorrect dose calculations during treatment planning.
Action
On March 28, 2018, the firm issued a Field Safety Notice, Medical Device Correction letter to its affected customers.
The firm instructed users to take the following actions:
-Do not use MLC only collimated to set output factor corrections (OFCs) in beam modeling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use ¿Jaws and MLC collimated¿.
-Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC
leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm.
Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this information by replying to the notification email.
This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this Field Safety Notice, all users must maintain awareness of this Field
Safety Notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A subset of medtronic model 53401 single chamber external pulse generators (epgs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected power on reset (por).
Action
Medtronic began notifying customers, via letter, on about 06/06/2018. Customers were instructed to verify if they possessed affected 53401 EPGs, if they did have affected EPGs to determine if the firmware was updated, to notify all appropriate personnel, to notify customers if the affected devices have been transferred, and to complete and return the Customer Confirmation Certificate.
Instructions for determining if the EPG firmware has been updated include: 1) powering the unit on and viewing firmware version; 2) if the firmware version is 01.03.00 or greater, the EPG firmware has been updated with the correction; and 3) if firmware version is 01.02.00, the EPG firmware has not been updated. Medtronic requests that customers arrange to have their EPGs returned for the firmware update.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The fixation of the upper and lower tilt actuator, of the omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with
high speed. this rotating movement can not be stopped by the user. this could potentially lead to the patient falling off the table. there is a risk of injury for the patient, user, or bystander.
Action
On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue.
Customers were instructed to do the following:
Stop using the system and call your Philips representative if any of the following situations occurs:
. the table height or tilt movement is not working.
. you notice a cracking sound or snapping sound different than the normal
sound during height or tilt movement.
. you experience a blockade in the table height or tilt movement during
system movements.
. the system is having an unexpected collision or the system had an
unexpected collision in the past 2 months.
. you have used a CPR stand that obstructed the system, or
. you notice any (other) unusual system behavior beyond the normal use
of the system.
Avoid collisions with the table and base stand of the system by ensuring that no
obstacles are placed around the system.
Customer shall ensure that all staff with access to the affected systems are
informed of the content of this Field Safety Notice.
A copy of this Field Safety Notice shall be placed together with the
documentation of the system until the system has been corrected by Philips.
The firm plans to correct all potentially affected products in the field by means of a field change order free of charge. Customers will be contacted by a local Philips representative to schedule the corrective action, which will start effective July 2018.
Customer with further questions may contact Philips Technical Support Line: 1-800-722-9377.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
The fixation of the upper and lower tilt actuator, of the omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with
high speed. this rotating movement can not be stopped by the user. this could potentially lead to the patient falling off the table. there is a risk of injury for the patient, user, or bystander.
Action
On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue.
Customers were instructed to do the following:
Stop using the system and call your Philips representative if any of the following situations occurs:
. the table height or tilt movement is not working.
. you notice a cracking sound or snapping sound different than the normal
sound during height or tilt movement.
. you experience a blockade in the table height or tilt movement during
system movements.
. the system is having an unexpected collision or the system had an
unexpected collision in the past 2 months.
. you have used a CPR stand that obstructed the system, or
. you notice any (other) unusual system behavior beyond the normal use
of the system.
Avoid collisions with the table and base stand of the system by ensuring that no
obstacles are placed around the system.
Customer shall ensure that all staff with access to the affected systems are
informed of the content of this Field Safety Notice.
A copy of this Field Safety Notice shall be placed together with the
documentation of the system until the system has been corrected by Philips.
The firm plans to correct all potentially affected products in the field by means of a field change order free of charge. Customers will be contacted by a local Philips representative to schedule the corrective action, which will start effective July 2018.
Customer with further questions may contact Philips Technical Support Line: 1-800-722-9377.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
If the c-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. as a result, the c-arm stops the movement and can drop up to 20 mm (0.8 ). under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the c-arm drop. this could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Action
On May 1, 2018, the firm distributed Urgent Medical Device Correction letters to its affected customers.
The letter instructed customers to follow standard emergency procedures they have in place in the event of system failures. The firm recommended considering reinforcing the emergency procedures until the update has been completed. As an immediate measure, operators were instructed to avoid driving the C-arm into a fully extended longitudinal position.
The firm is currently developing a solution to eliminate the root cause of the problem. The solution will be distributed to all affected customers upon completion.
Customers were asked to forward the safety information to any other organizations that could be affected.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Scissors, general, surgical - Product Code LRW
Reason
The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.
Action
The firm initiated the recall by letter on 06/12/2018.
All affected consignees are instructed to take the following actions:
"1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot numbers listed above.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter."
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Interventional fluoroscopic x-ray system - Product Code OWB
Reason
After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Action
On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure.
The firm stated that there should be no influence on the previous treatment of patients.
Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed.
The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, radiation therapy, charged-particle, medical - Product Code LHN
Reason
Correction vector confirmation message is lost if access point is changed after sending the correction vector. as a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Action
On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers.
Customers were advised to take the following actions:
It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation:
- verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement.
- verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement.
Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application.
A software update will be deployed on all affected sites by July 2018.
Customers with questions may email: vigiliance@iba-group.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Reason
Separation between lid and housing unit.
Action
Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Motor, Drill, Pneumatic - Product Code HBB
Reason
Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
Action
Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Reason
Gambro's clinicalkit 15g safety kits contain the nipro safetouch safety fistula needles currently being recalled by nipro for leakage problems.
Action
All consignees were notified by telephone and fax on 11/13/2002.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Reason
Gambro's clinicalkit 16g safety kits contain the nipro safetouch safety fistula needles currently being recalled by nipro for leakage problems.
Action
All consignees were notified by telephone and fax on 11/13/2002.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Reason
Field complaints of marker band spacing being out of spec.
Action
The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.