Recall Z-0328-05 ยท LNO
Abbott Laboratories
18 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener Set (List #51174) Assorted Single Use Sterile Jejunostomy Kits.
| 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 | 3247 jejunostomy 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
| K925102 | FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT Abbott Laboratories, Jun 9, 1994 |