Recall Z-1354-2018 ยท FPD Tube, Feeding
C.R. Bard, Inc.
Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-
| Date | Feb 27, 2018 |
| Status | Terminated |
| Reason | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. |
| Root cause | Finished device change control |
| Action | The firm initiate their recall by letter on 02/27/2018 by letter. The recall letter stated: "Action required: " Immediately examine your inventory and quarantine product subject to this recall. Please refer to the sample product labeling on Attachment 1 to help you locate the product. Do not use or further distribute any affected product. " Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected product. Additional instructions for product return are contained on the form. Upon receipt of t |
| Quantity | 42200 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.