Recall Z-0642-04 ยท KNT Tubes, Gastrointestinal (And Accessories)
Ross Products Division Abbott Laboratories
Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 14 Fr., 0.8 cm length, Item Numbers: 53126 and 55602.
| Date | Jul 20, 2004 (initiated Mar 1, 2004) |
| Status | Terminated |
| Reason | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. |
| Root cause | Other |
| Action | The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned. |
| Distribution | Nationwide; Australia, New Zealand, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962554 | FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE Abbott Laboratories, Nov 7, 1997 |