FDA Enforcement
Class II
Ongoing
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
Recall: Z-0798-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0798-2024
- Event ID
- 93679
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- C.R. Bard Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- December 20, 2023
- Classification Date
- January 25, 2024
- Address
- 8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States
Description
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
Reason
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.
Code Info
UDI/DI 00801741113246, Lot/Serial Numbers: NGDT1999, NGDU4285, NGDX0617, NGES3429, NGET1383, NGEU2115, NGEV4551, NGEX1978, NGEY0623, NGEY2687, NGFN0745, NGFN4316, NGFQ4111, NGFV3444, NGFW1905, NGFX2673, NGFX5526, NGGT4255, NGGU4246, NGGX5757
Distribution
US
Quantity
36440 units