18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list # 00238).
- Company
- Abbott Laboratories
- Recall Initiated
- November 12, 2004
- Posted
- December 21, 2004
- Terminated
- February 21, 2007
- Recall Number
- Z-0331-05
- Quantity
- 739 gastrostomy kits.
- Firm Location
- Columbus, OH
Reason for Recall
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
Distribution
The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
Lot / Code Info
Lots: 02581GZOO, 11884GZ00, 17159GZ00.
Root Cause
Other
Action Taken
The recalling firm notified customers by letter, dated 11/12/04.
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