Recall Z-1576-2015 ยท BRY Cabinet, Table And Tray, Anesthesia
B. Braun Medical, Inc.
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX
| Date | May 4, 2015 (initiated Mar 27, 2015) |
| Status | Terminated |
| Reason | There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space. |
| Root cause | Nonconforming Material/Component |
| Action | BBMI provided a recall notification letter, dated March 27, 2015, to distributors and end users in receipt of suspect product, along with acknowledgement forms detailing the suspect product that was distributed to each account. All customers were provided with instructions for disposition of suspect product in their inventory. Distributors were reminded of their responsibility in executing the recall. Returned product will be sent to the BBMI Distribution Center in Breiningsville, PA. |
| Quantity | 5000 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.