In October, 2021, NMPA published the AE and recall list reported by overseas manufacturers. Since China NMPA enhances the post-market surveillance, such AE and recall reasons can do help on manufacturers following China regulation.
Manufacturer
Product Name
Recall Class
Recall Reason
Cook Incorporated
Flexor Check-Flo Introducer Sets
II
The position of the radiopaque mark for two specific batches is wrong. The affected batches were not imported to China.
Becton Dickinson Infusion Therapy Systems, Inc.
BD Nexiva™ Closed IV Catheter System
III
There is a risk that the packaging of some models and batches of products is not tightly sealed, which may affect the sterility of the products. The affected batches were not imported to China.
Becton Dickinson Medical(S)Pte.Ltd.
BD PrecisionGlide™ Needle
III
BD received the complaints that the packaging of some batches is not tightly sealed, which may affect the sterility of the products. The affected batches were not imported to China.
B.Braun Medical
Implantable vascular access systems and accessories
III
The product model and UDI-DI code information on the label of the secondary packaging (outer box packaging) of some models and batches are missing. The affected batches were not imported to China.
Stryker Neurovascular
Trevo XP ProVue Retriever
III
The latest version of IFU is not included in the products to Saudi Arabia, which extends the application scope of the products compared with the previous version. Involved in some China products, but due to China regulation, the products in China follow Chinese IFU, so no impact in China.
Smith&Nephew, Inc.
Large Cannulated Screw System
II
The product label information is wrong. The label shows that the screw is full thread, but the real object is partial thread. The affected batches are not sold in China.
The CE mark on the label of the affected product shall be removed and not sold to the EU, Middle East and Africa. The affected batches are not imported to China.
Medtronic Inc.
Heart Suction Tube
II
The lead wire probe of cardiac drainage tube may pass through the tip of left ventricular exhaust catheter, with a probability of 0.0429%. If this problem is not noticed before surgery, the protrusion of the guide wire probe may cause tissue damage, resulting in a longer duration of surgery or surgical repair. Till August 9, 2021, Medtronic received 14 related complaints. Not involved in China.
Cook Incorporated
Transseptal Needle
I
There may be rust inside or outside the puncture needle. Potential adverse events that may occur if the affected product is used. Impacted China.
