Recall Z-0394-2017 ยท CAZ Anesthesia Conduction Kit
Becton Dickinson & Company
catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal
| Date | Aug 2, 2016 |
| Status | Terminated |
| Reason | A recall was initiated by Hospira, Inc. for several lots of 5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL Ampul, NDC # 0409-4712-01. Some BD" Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays. |
| Root cause | Nonconforming Material/Component |
| Action | BD sent recall letters/business reply card was sent via UPS/email on 8/2/2016. Stericycle is handling returns. |
| Quantity | 39,130 trays |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.