Recall Z-0336-05 ยท LNO
Abbott Laboratories
20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490).
| 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 | 3653 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
| K932861 | FLEXIFLO GASTROSTOMY KIT Abbott Laboratories, Jun 9, 1994 |