—#36041

Product

18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set (list # 50190).

FDA product code: LNO
510(k) numbers: K884275
Affected lot / code info: Lots: 02565GZ00, 03600GZ00, 04643GZ00, 05676GZ00, 06719GZOO, 10829GZ00, 10860GZ00, 11893GZ00, 12943GZ00, 13960GZ00, 14011GZ00, 14052GZ00, 15089GZ00, 16134GZ00, 16143GZ00, 18206GZ00, 84569GZ00, 86700GZ00, 88826GZ00, 89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00, 93261GZ00, 94322GZ00, 95410GZ00, 96470GZ00.

Why it was recalled

Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified customers by letter, dated 11/12/04.

Recalling firm

Firm: Abbott Laboratories
Address: 6550 Singletree Dr, Columbus, Ohio 43229-1119

Distribution

Distribution pattern: The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.

Timeline

Recall initiated: 2004-11-12
Posted by FDA: 2004-12-21
Terminated: 2007-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36041. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.