Device product
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Z-0150-2016
Product summary
- Event
- Event 72237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433
- Official record key
device-enforcement:Z-0150-2016
Official wording
Reason: Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
Code information: Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413
Distribution pattern: Nationally
Derived failure modes
-
Unknown
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.