Recall Z-0804-2024 ยท FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
C.R. Bard Inc
Bard Nasogastric Sump Tube and PreVent Filter and Lopez Valve with ENFit, 16Fr., 48in Long , REF EN0056160
| Date | Jan 25, 2024 (initiated Dec 20, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | BD (C.R. Bard) issued an URGENT Medical Device Recall Notice to its consignees via FedEx and email. The notice explained the problem with the devices, potential risks, and the devices be removed, quarantined, and discarded. Disseminate the notice to all users within the facility. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, wheth |
| Quantity | 8010 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960176 | DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER C.R. Bard, Inc., Jul 24, 1996 |