Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer B.Braun Melsungen AG on the recall of Cyto-Set, Cyto-Set Infusomat Space and Cyto-Set Mix lot No 3K14340000.
The manufacturer has advised users to stop using the affected lot of Cyto-St and return it to the manufacturer.
Here you may view the safety information addressed to users.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the volontary withrawal of certain batches of medical devices IMAGER II angiographic catheter, manufactured by Boston Scientific Corporation, USA, due to a detected quality defects in certain product batches.
Boston Scientific Corporation, USA, the manufacturer , has received reclamations about defective packagings, resulted from physical interactions between the carton on the pouch where the hub is located which may cause contamination of the product. Therefore, the manufacturer has taken precautions measures and decided to withraw all the affected batches.
IMAGER II angiographic catheters are sterile, single-use diagnostic intravascular catheters used exclusively in Health Care Facilities, are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.).
Medical Intertrade d.o.o., the registration holder of this medical device in Croatia, has recalled all nine batches found on the Croatian market affected by afore mentioned defect.
None of the adverse events referred to the described packaging defect of IMAGER II angiographic catheter has been reported by now in the Republic of Croatia.
The manufacturer has run an investigation and has found out the cause for packaging defects and has initiated corrective measures in order to prevent the reappearence of those defects.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Carestream Health, Inc. on the possibility of an earlier damage on the junction of scissors arm holder in intraoral Röntgen systems Kodak 2100 and Kodak 2200.
The manufacturer has discovered the problem on devices delivered in the time period between May 2008 and April 2010 and advises users to check the devices for damage signs even before visit to service engineers.
Here you may view the safety information addressed to users.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

Medicina trgovina d.o.o., the holder of the registry enrollment of the medical device has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to urgently recall one lot of the stomach tube CH 18 medical device of the manufacturer Changshu Taining Medical Equipment Co. Ltd, China due to a suspected product quality defect. The LOT 20100120 is being recalled by this decision.
On 26 July 2012, HALMED received a report from a health care facility about an unopened, sterile packaging of the aforementioned product in which, through a protective folio, a strange body that may possibly cause a contamination of the product, was observed. Therefore, HALMED informed the holder of the enrollment registry, who from precautions decidet to recall the aformentioned lot.
The stomach tube CH 18 is used for aspiration of the gastric content and it is intended for use in health care facilities.
Medicina trgovina do.o., the holder of the registry enrollment of the medical device has informed health care facilities in Croatia about the recall of the aforementioned lot found on the Croatian market.
In the Republic of Croatia has not been reported any adverse event associated with the described problem with the stomach tube CH 18 medical device.
The aforementioned lot of the medical device will be recalled untill the end of validity testing of other packagings of the same lot.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received from a medical device manufacturer CooperVision, England, a notification on the recall of the medical device Proclear toric contact lenses.
The manufacturer has discovered by its own quality system that a limited number of batches is minimally produced out of specification and therefore decides to voluntary recall the product from the market.
Taking account that there is no risk for users, the recall of the batches 100375500080080717, 104235500040220516 and 104275000160220117 is being carried out at the retail level. According to manufacturer’s records, 4 packs with 6 contact lenses each, have been delivered to the Republic of Croatia.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Datex-Ohmeda, Inc. (GE Healthcare) reminding users on the importance of occasional device shutdown/restarting and self-testing at restarting.
The manufacturer reminds users that devices start alarm for shutdown/restarting due to self-testing, if devices work continuously longer than 12 hours and may stop working if they are continuously on longer than 49 days.
Here you may view the safety information addressed to users.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro - glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope - Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
The registration holder of the medical device, Johnson & Johnson S.E. do.o. has in collaboration with the manufacturer LifeScanEurope - Division of Cilag GmbH International, Switzerland initiated a safety corrective measure recalling the product OneTouch®Pro from the market. The defective product will be replaced by an accurate one.
Hereby we inform all users to stop using the product OneTouch®Pro - glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro - glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
No adverse event report associated with the use of OneTouch®Pro - glycaemic self-management system has been received in Croatia by now.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer MEDTRON AG, Germany, an information about the recall of certain medical device batches 200ml ELS syringe for contrast media dosing.
The manufacturer has provided instructions for users not to use the affected batches.
Here you may view the safety information for users with the list of affected batches.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Medtronic Inc. on the change of the iEOA table and size measuring device for Mosaic aortic bioprosthesis of the model 305 due to reports to higher than expected transvalvular gradients occurred after implantation.
The manufacturer has informed users that older versions of tables and measuring device will not be distributed anymore.
Here you may view the safety information addressed to users.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received an information from the holder of the enrolment into the medical device registry, Oktal Pharma d.o.o., Zagreb and retrospectively the information from the manufacturer’ representative, Medtronic B.V./Adriatic Region Zagreb about the corrective measures related to the Paradigm infusion sets manufactured by Medtronic MiniMed, USA.
The information is related to the following medical devices:
The manufacturer of the medical device Paradigm reservoirs has identified that certain models of this product may leak, due to a manufacturing defect, which may result in under delivery of insulin and failure. In addition, the manufacturer of the medical device Paradigm infusion sets used with insulin pumps has identified a potential safety issue if insulin or other fluids come in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector. This is most likely to occur after the insulin reservoir is filled. If this occurs, fluid can temporarily block the vents in the connector that allow the pump to prime before use. This can result in too much or too little insulin being delivered to the patient, which can cause hypoglycaemia or hyperglycaemia and require immediate medical attention.
The holder of the entering into the medical device registry, Oktal Pharma d.o.o., Zagreb, has in collaboration with the manufacturer’s representative Medtronic B.V./Adrioatic Region, Zagreb and manufacturer, Medtronic MiniMed, USA, initiated two corrective safety measures resulting in a preventive recall of certain lots of the medical device Paradigm reservoirs with lot numbers MMT326A and MMT-332A and providing further information and advice to healthcare professionals and users of the Paradigm infusion sets about the possibility of under- or over-delivery of insulin or other liquids coming in contact with the inside of the Medtronic Paradigm insulin infusion set’s connector.
The safety information for healthcare professionals and patients related to this recall of certain lots of the medical device is accessible here. The safety information for doctors and patients about the problem of the Paradigm infusion set is accessible here (notice-doctors; notice- patients) (in Croatian).
There was no reported adverse incidents in the Republic of Croatia associated with this problem.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Ortho Clinical Diagnostics, England, an information about the addendum to the safety corrective action regarding the ORTHO BioVue System Cassette for immunohematology.
The manufacturers has provided users with the revised risk assessment and table of possible impact on test results.
The safety information for users with the list of affected batches is available here.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

Q-Med, the manufacturer has decided to discontinue the promotion of Macrolane for breast enhancement as it may interefere with the reading of mammograms. In those cases, additional ultrasound examinations are needed. Macrolane may sometimes in certain cases cause harmless lumps in brest, which results with unnecessary examinations and patient anxiety.
Macrolane is a non-permanent gel consisting of stabilised hyaluronic acid and it is intended for temporary augmentation, volume restauration and body contour shaping. The promotion of Macrolane is being discontinued for breast enhancement only due to the interference in radiology diagnostics. Macrolane is a safe product with regard to the fact that hyaluronic acid is a natural component of human tissues and is in certain time period degradable by natural processes.
Macrolane may be further on promoted for volume augmentation of other body surface parts, i.e. buttocks, calfs, breast in men etc., as well as for restauration and shaping of dammaged body contours, caused by soft tissue defects, i.e. lipoatrophy.
In Croatia, Macrolane is not widely used and it is implanted in only two patients, who will be informed by their doctors about the change in the use of this product. Proximun d.o.o., the registration holder has committed himself to inform all the users about this change. The change in the use of macrolane medical device will be included in the information leaflet and labelling of this product.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received from the medical device manufacturer Roche Diagnostics GmbH an information about the omission in the instructions for use. Namely, the maximal life cycle of 52 weeks of reference electrodes on diagnostic systems Roche OMNI C, Roche OMNI S, cobas b 221, b121 and b121.
The manufacturer has advise users to replace the referent electrode if it is older than 52 weeks and will provide a new version of software support including a reminder for electrode replacement. The complemented version of the instructions for use will be delivered to users.
The safety information is available here and here.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received the information from the medical device wholesaler Ma-Co Plast d.o.o, about the preventive recall of the LOT 2013-01 of the Infusion Set due to its non-conformity with the Regulation (EC) 1907/2006.
The decision about the preventive recall has been taken in collaboration with HALMED, after the test results of the aforementioned medical device lot revealed that the content of bis(2-ethylhexyl)ftalate was above the maximum allowed level set out in the Regulation (EC) 1907/2006.
The end users are informed in a letter to quit preventively using transfusion sets from the same manufacturer Shandong Qiaopai Group Co,. Ltd and separate them from other products before the test results have been obtained.
Here you may read the letter to the end users.
No adverse incident related to this medical device has been reported in the Republic of Croatia by now.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has recommended a temporary suspension of implantation of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has been discontinued in the Republic of Croatia. The suspension has been due to precautions after an unannounced inspection at the manufacturing site in Brasil discovered a impurity with particles on the surface of certain products of this manufacturer. According to the currently available safety data there are no indications that this issue could have a harmful effect on the health of patients with these implants.
HALMED, in collaboration with other European competent authorities for medical devices, recommends a temporary discontinuation of implantation of all implants of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has temporarily been suspended. The suspension is due to a particle impurity detected on the surface of the product discovered in an unannounced inspection. The manufacturer has been temporarily suspended for CE marking of the products, which is a prerequisite for placing products on the EU market. The temporary suspension of use of these products will be in effect until release of further recommendations, or finalisation of the investigation jointly conducted by the European competent authorities, including HALMED. Within this comprehensive European investigation, relevant tests will bill conducted in order to identify possible risks for users of the concerned products. According to the all currently available data, there are no indications that this issue could have a harmful effect on the health of persons with these implants.
Therefore, individuals with these implants are for now advised not to take any further steps than ordinary ones and regular controls according to doctor’s recommendations. In the case of concern patients should speak to their doctor who implanted the product.
All products of the manufacturer Silimed are subject to suspension: silicone implants for plastic and general surgery, implants for urology and surgical products for obesity treatment.
HALMED has not received by now any adverse incident associated with these medical devices.
HALMED continuously monitors the safety of all medical devices from the close through the Croatian medical device vigilance system and will promptly make any new information publically available.
Further information
HALMED has together with other European competent authorities for medical devices received a notification on the temporary suspension of validity of the certificate of conformity including all medical devices of the Brasilian manufacturer Silimed. This also includes the suspension of the manufacturer’s right to CE mark its products as a prerequisite for placing products on the EU market. A German competent authority that initially issued the certificate of conformity, in an unannounced inspection of the manufacturing site in Brasil discovered particle impurities on the surface of certain products.
Medical devices may not be placed on the EU market without the CE mark. The CE mark is affixed on the product by the manufacturer after the product has complied with all regulatory requirements. This mark confirms that the medical device is correct and safe if handled as indicated in the instructions and according to the use declared by the manufacturer. The CE mark guarantees the conformity of the product with the essential requirements set out in the EU directives that are transposed in the Croatian legislation.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, GmbH on the change in cleaning and sanitation of Zimmer othopedic surgical instruments.
The manufacturer has amended Instructions for care, maintenance and sterilisation of Zimmer instruments in chapters 8F, 8I and 11 of the Manual for orthopaedic surgical instruments.
Here you may view the safety information addressed to users.

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Zimmer, Inc., SAD on the changes in instructions for use and applicable surgical technique due to complaint reports to hyperextension of polyethylene inserts.
Here you may view the safety information addressed to users.