Recall Z-0335-05 ยท LNO
Abbott Laboratories
20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (list #50738).
| 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 | 822 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
| K915110 | FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT Abbott Laboratories, Apr 14, 1992 |