FDA Device

14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.

Hazard

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

What You Should Do

Remedy

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

Products

14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
Brand
Abbott Laboratories
UPC
Lots: 04639GZ00 and 17182GZ00.

Units Affected

61 kits.