Recall Z-0174-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems Inc.
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
| Date | Nov 3, 2022 (initiated Oct 12, 2022) |
| Status | Open, Classified |
| Reason | During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed). |
| Root cause | Storage |
| Action | On 10/12/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx and email, to customers informing them that Becton, Dickinson (BD) confirmed that during withdrawal of the Nexiva product, the tip shield may prematurely separate from the catheter adapter and prevent the needle tip from being safely shielded. As a result, the clinicians could potentially experience a contaminated needlestick injury after withdrawal of the needle. Customers are instructed to: 1. Immediately review their inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all unused produ |
| Quantity | 56,080 units |
| Distribution | U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A |
| 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 |