Device product
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Z-0567-2018
Product summary
- Event
- Event 78878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8630 units
- Official record key
device-enforcement:Z-0567-2018
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 tothe 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: 0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter