Z-0941-05

Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook...

Name: Z-0941-05 Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook...
Creator: Wilson-Cook Medical Inc
Published: 2005-06-09
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2005-06-09 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road *... on 2005-06-09. The reason FDA records is "The reorder number listed on the product label is inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0941-05
Status: Terminated
Initiated: 2005-06-09
Posted: 2005-06-28
Terminated: 2005-09-21
Recalling firm: Wilson-Cook Medical Inc.
Product: Low Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The reorder number listed on the product label is inaccurate.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by email/fax on 06/17/2005.
Quantity in commerce: 6 units
Distribution: Brazil, Japan & Hong Kong
Product codes and lots: Lot Number: WR1827952, Labeled Reorder Number LPG-20-2.4-A and Lot Number W1834577, Labeled Reorder Number PASS-20-3.4-A

Product code KNT

K920579Class IILow Profile Passport Push & Pull Kits & Peg TubeWilson-Cook Medical, Inc. / cleared 1994-07-08

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)