NMPA intensively reported that many well-known machinery enterprises were called! Johnson…
Recently, the NMPA released a number of medical device recall information, involving Medtronic, Johnson & Johnson, Boston Scientific, 3M and other well-known national equipment companies, and a number of recall levels reached the second level.
- Boston Scientific Corporation initiated a voluntary recall of Subcutaneous Implantable Defibrillator
Boston International Medical Trading (Shanghai) Co., Ltd. reported that due to the specific model and batch of products involved, there was a date/time stamp error in the software of subcutaneous implantable cardioverter defibrillator, which may result in the incorrect display of the remaining battery power. The manufacturer Boston Scientific Corporation initiated a recall of Subcutaneous Implantable Defibrillator (Registration Certificate No. : GXZJ 20153122410).
The recall level was level 2.
- Medtronic Inc. voluntarily recalled Implantable Deep Brain Neurostimulator
Medtronic (Shanghai) Management Co., Ltd. reported that Percept PC cannot communicate wirelessly with patient program controller or clinician program controller during continuous treatment for patients due to specific models and batches of products. The manufacturer Medtronic Inc. voluntarily recalled Implantable Deep Brain Neurostimulator (Registration Certificate No. : GXZJ 20223120364).
The recall level was level 2.
- Ethicon, Inc. has voluntarily recalled the absorbable suture PDS II (polydioxanone) synthetic absorbable suture
Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. reported that the tensile strength of suture products was lower than the internal control requirements due to the involvement of specific models and batches of products. Ethicon, Inc., the manufacturer, actively recalled the absorbable suture PDS II (polydioxanone) synthetic absorbable sutures (Registration Certificate No.: GXZJ 20153023300).
The recall level was level 3.
- 3M Company, 3M Health Care voluntarily recalls Blood/Fluid Warmer Device for single use （Registration Certificate No.: GXZJ20163142341）
Minnesota Mining Manufacturing (Shanghai) International Trading Co., Ltd. reported manufacturing problems with automatic exhaust valves/debubbler due to a specific model and batch of product involved. 3M Company, 3M Medical Products Division, 3M Health Care voluntarily recalls the disposable Blood/Fluid Warmer Device for single use (Registration No. : GXZJ 20163142341).
The recall level was level 2.
- Oxford Immunotec Ltd. Voluntary recall of the Mycobacterium tuberculosis specific cellular immune response test kit (immune spot method) T-SPOT.TB
Oxfordimmunotec Ltd. reported that the manufacturer Oxford Immunotec Ltd. actively recalled the specific cell immune response test kit (immunodot method) T-SPOT.TB (Registration Certificate No.: GXZJ 20,143,405,783) of Mycobacterium tuberculosis due to the wrong expiry date of the product in the label of the kit, which involved specific models and batches of products(Registration No. : GXZJ 20143405783).
The recall level was level3.
- Leica Biosystems Newcastle Ltd voluntarily recalled Bond Ready-to-Use Primary Antibody bcl-6 (LN22)
Leica Microsystems (Shanghai) Trading Co., Ltd. reported that due to the specific model and batch of products involved, there was an error in the allocation of reagent batch number and expiry date, and the actual concentration of the product was lower than the concentration indicated on the label, Leica Biosystems Newcastle Ltd, the manufacturer, actively recalled the bcl-6 antibody reagent (immunohistochemistry) Bond Ready to Use Primary Antibody Bcl-6 (LN22) (filing number: GXB No. 20180889).
The recall level was level 3.
- Bard Peripheral Vascular, Inc. actively recalled Breath Biopsy Probe and accessories
Bard Medical Technology (Shanghai) Co., Ltd. reported that foreign matters were found at the end of the breast rotary cutting puncture needle due to the involvement of specific models and batches of products. The manufacturer Bard Peripheral Vascular, Inc. actively recalled the Breast Rotary Cutting Puncture Needle and its accessories Breath Biopsy Probe (Registration Certificate No.: GXZJ 20173016309).
The recall level was level 3.
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Source：NMPA
Translated & edited by Bradyknows
