Z-0174-2023 Class II Ongoing
FDA device recall Z-0174-2023 was initiated by Becton Dickinson Infusion Therapy Systems Inc. on October 12, 2022 and is designated Class II. Reason for recall: 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). The recall status is ongoing. Affected quantity: 56,080 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- October 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,080 units
Product Description
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)
Reason for Recall
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).
Distribution Pattern
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
Code Information
Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865