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 welch allyn aed 20 product may display a 'defib comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropiate therapy.
Action
Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.
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
Ventilator, Continuous, Facility Use - Product Code CBK
Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.
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
Activated Whole Blood Clotting Time - Product Code JBP
Reason
Validation had been initiated for a molded component of the finished device but not completed. also, the device did not meet mean clotting time using normal donor blood as media.
Action
Recall letter was sent out on 4/27/2005 via First Class Mail.
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
Heart-Valve, Allograft - Product Code MIE
Reason
This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.
Action
Consignees were notified by telephone and letter on 04/19/2004.
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 x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
Action
Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.
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 x-ray tube housing assembly may have been mounted with the incorrect sized bolts.
Action
Dunlee sent recall letters dated 4/4/05 to end user locations, informing them that Dunlee and their service representatives would visit each location to replace the mounting bolts on all Dunlee DA-200 Performix installations because of problems experienced at certain GE CT installations. Any questions were directed to John M. Macko, Product Marketing Manager, at 630-585-2174.
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 defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
Action
The recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.
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
Enzyme Immunoassay, Valproic Acid - Product Code LEG
Reason
Negatively biased results may be observed when the reagent is stored on the vitros 5,1fs chemistry system for less than seven days.
Action
Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.
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
Anesthesia Conduction Kit - Product Code CAZ
Reason
Becton dickinson recalled the needles due to reports of leakage associated with an undersized luer taper in the spinal needle hub.
Action
The firm initiated the recall via letter on April 15, 2005.
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 device may disarm and not deliver shock when performing a synchronized cardioversion.
Action
Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.
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
Anesthesia Conduction Kit - Product Code CAZ
Reason
Becton dickinson recalled the needles due to reports of leakage associated with an undersized luer taper in the spinal needle hub.
Action
The firm initiated the recall via letter on April 15, 2005.
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.
Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
Action
The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required.
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.
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the philips allura fd10.
Action
On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.
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
Blade, Scalpel - Product Code GES
Reason
A small percentage of scalpels exhibited a 'double blade' condition.
Action
Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005.
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
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Reason
The transport chain is used to move a reaction tube within the immulite 2000. it goes on to state the error condition that occurs due to a false trip of the home sensor.
Action
The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.
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
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Reason
Holes in thermoformed tray compromising the sterility of the 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.
Extra notes in the data
Stent, Coronary - Product Code MAF
Reason
Potential for deployment difficulties.
Action
Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned.
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
Urinalysis Controls (Assayed And Unassayed) - Product Code JJW
Reason
Nonconformance to performance specifications.
Action
Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.
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
Radioimmunoassay, Acth - Product Code CKG
Reason
Performance does not meet claims in the directional insert concerning correlation with the irma acth assay.
Action
Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
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
Clamp, Surgical, General & Plastic Surgery - Product Code GDJ
Reason
Cupped grasper handle marked incorrectly as duckbill upbiter.
Action
Smith & Nephew Endoscopy notified users by letter dated 4/6/05. Accounts are requested to return 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.
Extra notes in the data
Test, Time, Partial Thromboplastin - Product Code GGW
Reason
Variable clotting times observed with the ptt-la, lupus anticoagulant-sensitive aptt reagent.
Action
On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
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
Generator, Oxygen, Portable - Product Code CAW
Reason
Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
Action
Recall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.
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
Regulator, Vacuum - Product Code KDP
Reason
Condition exists that prevents complete shutoff of the valve.
Action
The recalling firm telephoned their customers on 7/25/05 to inform them of the problem, request the return of the recalled product, and inform them that replacement products were being shipped