Z-0960-05

10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442)

Name: Z-0960-05 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442)
Creator: Abbott Laboratories
Published: 2005-06-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-06-18 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442) on 2005-06-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0960-05
Status: Terminated
Initiated: 2005-06-18
Posted: 2005-07-07
Terminated: 2008-10-24
Recalling firm: Abbott Medical
Product: 10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442).
Product code: LNO
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees.
Quantity in commerce: 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.
Product codes and lots: 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

Product code LNO

K925102Class IIFlexiflo Laparoscopic Jejunostomy KitAbbott Laboratories / cleared 1994-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)