Recall Z-0189-04 ยท KNT Tubes, Gastrointestinal (And Accessories)
Ross Products Division, Abbott Laboratories
Ross 22 FR Gastrostomy Tube, Item #156.
| Date | Jul 20, 2004 (initiated Nov 14, 2003) |
| Status | Terminated |
| Reason | An increase in reported balloon failures, which may result in tube displacement. |
| Root cause | Other |
| Action | The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned. |
| Distribution | Nationwide. Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861323 | REPLACEMENT GASTROSTOMY TUBE Microvasive, Dec 16, 1986 |