10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
FDA device recall Z-0960-05 · posted 2005-07-07 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- 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.
- Action taken
- The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNO
- Quantity affected
- 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 c
- Date initiated
- 2005-06-18
- Date posted
- 2005-07-07
- Date terminated
- 2008-10-24
- Location
- Columbus, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT (K925102) | Abbott Laboratories | 1994-06-09 |