FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
- Recall number
- Z-0960-05
- Recalling firm
- Abbott Laboratories
- Product
- 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
- Status
- Terminated
- Initiated
- 2005-06-18
- Posted
- 2005-07-07
- Terminated
- 2008-10-24
- 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; WM Beaumont Army Medical Center, 5005 N. Piedras St., El Paso, TX 79920; Dallas VA Medical Center #549, 4500 S. Lancaster Rd. #44, Dallas, TX 75216; VA Hospital General Warehouse #648, 3710 SW US Vet Hospital Rd., Portland, OR 97201; VA Medical Center #558, 508 Fulton Street, Durham, NC 51442; VA Medical Center #605, 11201 Benton, Loma Linda, CA 92357; VA Medical Center, #630, 423 E. 23rd Street, New York, NY 10010; VA Medical Center #636, 4101 Woolworth Ave, Omaha, NE 51442; VA Medical Center #640, 3801 Miranda Ave., Palo Alto, CA 94304; VA Medical Center #650, 830 Chalkston Ave., Providence, RI 29080; VA Medical Center #662, 4150 Clement St., San Francisco, CA 94121; VA Medical Center #689, 950 Campbell Ave., West Haven, CT. 65160; VA Medical Center #521, 700 S. 19th Street, Birmingham, AL 35233; VA Medical Center Chief Supply, 113 Holland Ave., Albany, NY 12208; VA Medical Center #554, 1055 Clermont St., Denver, CO 80220; VA Medical Center #671, 7400 Merton Minter, San Antonio, TX 78284; Veterans Canteen SVC 587, 915 N. Grand Blvd., St. Louis, MO 63106.
- Lot, serial or model codes
- Lot 13978GZ, exp. date 02/01/2007; Lot 17165GZ, exp. date 06/01/2007; Lot 18190GZ, exp. date 07/01/2007; Lot 19257GZ, exp. date 08/01/2007; Lot 22355, exp. date 11/01/2007; Lot 24440GZ, exp. date 01/01/2008; Lot 26509GZ, exp. date 02/01/2008; Lot 27530GZ, exp. date 02/01/2008
- 510(k) numbers
- ["K925102"]
- PMA numbers
- not on file
- Product code
- LNO
- Firm FEI
- 1527460
- Firm city
- Columbus
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28