Recall Z-0333-05 ยท LNO
Abbott Laboratories
22 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring Tube Removal without Endoscopy (list # 50520).
| Date | Dec 21, 2004 (initiated Nov 12, 2004) |
| Status | Terminated |
| Reason | Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed. |
| Root cause | Other |
| Action | The recalling firm notified customers by letter, dated 11/12/04. |
| Quantity | 649 gastrostomy kits. |
| Distribution | The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903325 | FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT Abbott Laboratories, Nov 19, 1990 |