Z-0801-2024 Class II Ongoing
FDA device recall Z-0801-2024 was initiated by C.R. Bard Inc on December 20, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 187550 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- December 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187550 units
Product Description
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
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.
Distribution Pattern
US
Code Information
UDI/DI 00801741113901, Lot/Serial Numbers: NGFU2486, NGFU3807, NGFW1859, NGFX0062, NGFX5625, NGFY0610, NGFZ1664, NGGR0346, NGGR2172, NGGS0703, NGGS2557, NGGS3418, NGGYY001, NGHN0893, NGHQ3357, NGHQ3358, NGHQ3359, NGHQ3383, NGHQ3384, NGHR0028, NGHR0029, NGHR0030, NGHR0031, NGHR0032, NGHR0072, NGHR0073, NGHR0074, NGHR0075, NGHR0159, NGHV0889, NGHV2621, NGHV2722, NGHV3877, NGHW0569, NGHW1488, NGHW3036, NGHW4578, NGHX0643, NGHX0869