Device product
Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Z-0571-2018
Product summary
- Event
- Event 78878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6720 units
- Official record key
device-enforcement:Z-0571-2018
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: 0061482582. 0061509281. 0061523764. 0061539142. 0061541519. 0061545624. 0061549251. 0061523766. 0061536442. 0061549079. 0061525251. 0061536434. 0061534703. 0061480989. 0061486228. 0061519902. 0061523684. 0061530885. 0061536042. 0061539966. 0061546081. 0061550336.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter