14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
- Company
- Abbott Laboratories
- Recall Initiated
- November 12, 2004
- Posted
- December 21, 2004
- Terminated
- February 21, 2007
- Recall Number
- Z-0327-05
- Quantity
- 61 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: 04639GZ00 and 17182GZ00.
Root Cause
Other
Action Taken
The recalling firm notified customers by letter, dated 11/12/04.
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