Recall Z-0150-2016 ยท CAZ Anesthesia Conduction Kit
B. Braun Medical, Inc.
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
| Date | Aug 27, 2015 |
| Status | Terminated |
| Reason | Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier. |
| Root cause | Under Investigation by firm |
| Action | BBMI provided written notification, dated August 27, 2015, to all customers in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. These customers include both BBMI direct end customers and BBMI direct distributors. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors shall be reminded of their responsibility in executing the recall. |
| Quantity | 433 |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962696 | PERIFIX PEDIATRIC EPIDURAL KIT B.Braun Medical, Inc., Apr 3, 1997 |