Device product
Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Z-0576-2018
Product summary
- Event
- Event 78878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-0576-2018
Official wording
Reason: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Code information: 0061539146. 0061540984.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter