Recall Z-1666-2014 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
B. Braun Medical, Inc.
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
| Date | May 28, 2014 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles. |
| Root cause | Nonconforming Material/Component |
| Action | B/Braun sent an Urgent Medical Device Recall Notification letter dated April 3, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Device Recall Notification in its entirety and ensure that all users in their organization and other concerned persons are informed about this voluntary product recall. The letter should also be forwarded to their customers. Customers were instructed to determine their current inventory of the affected lots within their facility, DO NOT DESTROY ANY |
| Quantity | 7400 |
| Distribution | Worldwide Distribution - USA (nationwide) and to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY B. Braun of America, Inc., Jan 26, 1994 |