Recall Z-0740-2017 ยท OFT Spinal Epidural Anesthesia Kit
Becton Dickinson & Company
BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
| Date | Dec 12, 2016 (initiated Nov 7, 2016) |
| Status | Terminated |
| Reason | BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069. |
| Root cause | Error in labeling |
| Action | BD sent an Urgent Product Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately review their inventory for the affected product. Return the affected products with the Business Response Card form following the instruction on the enclosed packing instruction. The completed form should be faxed to 1-866-240-5212 or email the completed form to bd6549@stericycle.com. Customers with questions were instructed to call 1-866-792-5451. For questions regarding |
| Quantity | 4500 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.