14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
FDA Recall Z-0327-05 · Posted 2004-12-21
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeLNO
Date Initiated2004-11-12
Date Terminated2007-02-21
Product Quantity61 kits.
Reason for Recall
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
Firm Action
The recalling firm notified customers by letter, dated 11/12/04.
Root Cause
Other
Distribution Pattern
The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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