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Terminated

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

FDA Recall Z-0960-05 · Posted 2005-07-07

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeLNO
Date Initiated2005-06-18
Date Terminated2008-10-24
Product Quantity2,174 kits

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.

Firm Action

The recalling firm sent a device correction recall letter dated 6/16/05 by overnight courier to all consignees.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925102FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KITAbbott Laboratories · 1994-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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