In July, NMPA has released 17 recalls regarding the imported medical devices in China. The table below is a summary for the recalls of the overseas manufacturers. Since China NMPA enhances the post-market surveillance, Inspirative Medical can help manufacturers review all labels in compliance to China regulations.
Manufacturer
Product Name
Recall Classification
Recall Reason
Medtronic Inc.
Neurostimulation Lead
I
Due to the manufacturing problems of specific models and batches of products, additional protrusions may appear on the edge of the support clip in the stimloca drilling cover of specific batches, which may affect the normal use and performance of the products
Medtronic Inc.
Insertable Cardiac Monitor (ICM)
II
All ICM may have partial electrical reset, with an incidence of 0.049%. This will cause the device to no longer automatically detect “bradycardia” and “cardiac arrest” events. The potential harm of this problem includes delayed medical intervention, missed diagnosis, surgical removal of equipment, etc.
Smith & Nephew Orthopaedics Ltd.
BIRMINGHAM HIP Manual Instrument
II
Specific models and batches of products are produced using specifications not approved by Smith & nephew, resulting in different linking methods of the square head nails.
William Cook Europe ApS
Frova Intubating Introducer
II
A hardened casing is incorrectly provided in a specific model and batch of products.
Cardiac Pacemakers Incorporated
Implantable Bradycardia pacemaker
I
At the end of the service life of the device of a specific model and batch of products, when the internal impedance of the battery is high and the program-controlled inquiry of the device is attempted, the device may turn into the safe mode. This potential battery condition will put the device at the risk of system reset.
W.L. Gore & Associates, Inc.
Molding Balloon Catheter
II
When testing or using the product before preparation, it is found that the wire guide cavity of a specific model and batch of products and the tail adhesive port of the Y-joint leak, which may lead to insufficient or unable filling of the balloon.
Siemens Medical Solutions USA, Inc.
Diagnostic Ultrasound System
II
For specific models and batches of products, some systems with battery packs installed may not start the equipment normally without external power supply.
Abbott Diagnostics Technologies AS
Alere Afinion AS100 Analyzer
III
There is a problem with the Alere Afinion AS100 Analyzer. If the analyzer is stored for a long time (1.5-2 years) without power connection, the internal clock battery of the analyzer may be exhausted before the expected service life, which will cause the analyzer to fail to work normally through self-test.
Abbott GmbH
2nd Generation Testosterone Reagent Kit
III
The bar code of the testosterone test kit for a specific model and batch of products does not match the latest project file.
10. Roche Diagnostics GmbH
cobas u 701 microscopy analyzer;cobas u 601 urine analyzer
II
Due to software limitations, the sample results of Cobas 6500 automatic modular urinalysis detection system (software version 2.3.6) may not match.
Cook lncorporated
Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating
III
The fixation strength test results of 6Fr Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating did not meet the standards specified in the product technical requirements
Ortho-Clinical Diagnostics,Inc.
VITROS 3600 Immunodiagnostic System; VITROS 5600 Integrated System
III
After service access, some VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System may retain the configuration that allows users to use expired reagents and calibrators due to personnel negligence
E.M.S. Electro Medical Systems S.A.
Prophylaxis powder
III
The transportation and storage temperature information on the batch number product package is incorrect, which may cause misunderstanding by users.
Carl Zeiss Meditec AG
Intraocular Lens
III
The model and specification of the Chinese label of the product are wrong.
Boston Scientific Corporation
Subcutaneous Electrode
I
Specific models and batches of products may break at the distal end of the proximal sensing electrode, resulting in failure to provide defibrillation treatment and high resistance group alarm.
Tosoh Corporation
Automated Enzyme Immunoassay Analyzer
III
The rated power on the product label of a specific model and batch of products is printed incorrectly.
Creganna Medical
Trapper™ Exchange Device
III
The poor connection between the seat and balloon cavity of a specific model and batch of products leads to the difficulty or failure of distal balloon filling.
