Recall Z-0125-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
| Date | Sep 14, 2020 |
| Status | Terminated |
| Reason | Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted |
| Root cause | Nonconforming Material/Component |
| Action | Siemens issued an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/20 to Distributors/Medical Facilities on 9/14/20 via FedX , email or faxed stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. Compl |
| Quantity | 12,020 units |
| Distribution | US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183399 | BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems, Inc., Mar 20, 2019 |