Z-0331-05

18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list #...

Name: Z-0331-05 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list #...
Creator: Abbott Laboratories
Published: 2004-11-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-11-12 / Terminated / root cause: sterility

FDA source

Abbott Laboratories began a recall of 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list # 00238) on 2004-11-12. The reason FDA records is "Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0331-05
Status: Terminated
Initiated: 2004-11-12
Posted: 2004-12-21
Terminated: 2007-02-21
Recalling firm: Abbott Medical
Product: 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list # 00238).
Product code: LNO
Reason for recall: Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
Root cause tag: sterility
FDA root cause: Other
Action: The recalling firm notified customers by letter, dated 11/12/04.
Quantity in commerce: 739 gastrostomy kits.
Distribution: The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
Product codes and lots: Lots: 02581GZOO, 11884GZ00, 17159GZ00.

Product code LNO

K910332Class IIFlexiflo Sacks-Vine Gastrostomy KitsAbbott Laboratories / cleared 1991-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)