Recall Z-0960-05 ยท LNO
Abbott Laboratories
10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
| Date | Jul 7, 2005 (initiated Jun 18, 2005) |
| Status | Terminated |
| Reason | The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots. |
| Root cause | Other |
| Action | The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees. |
| Quantity | 2,174 kits |
| Distribution | The product was distributed to hospitals throughout the United States. Government accounts to which the product was distributed to were 2 Department of Defense accounts and 15 Veteran Administration centers including : Wilford Hall USAF Medical Center, 2200 Bergquist Dr., #1, Lackland AFB, TX 78236; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925102 | FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT Abbott Laboratories, Jun 9, 1994 |