FDA Device

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

Hazard

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.

What You Should Do

Remedy

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

Products

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

Units Affected

2,174 kits