Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
FDA Recall #Z-0795-2024 — Class II — December 20, 2023
Product Description
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
Reason for Recall
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Recalling Firm
C.R. Bard Inc — Covington, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
39430 units
Distribution
US
Code Information
UDI/DI 00801741113765, Lot/Serial Numbers: NGEV2409, NGEY1492, NGEY2717, NGEZ0908, NGEZ1657, NGEZ2692, NGFQ4105, NGFR1077, NGFR2312, NGFR3259, NGFS1627, NGFS4431, NGFT5468, NGFU1877, NGFU3837, NGFV1652, NGFV3513, NGFW1856, NGFX0167, NGFX2672, NGFX5611, NGGP3169, NGGT3611
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated