Z-0377-2007

Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL

Name: Z-0377-2007 Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL
Creator: Cook Urological, Inc.
Published: 2007-01-05
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-01-05 / Terminated / root cause: packaging

FDA source

Cook Urological, Inc. began a recall of Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL on 2007-01-05. The reason FDA records is "Lack of assurance of sterility, as the packages may not have been sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0377-2007
Status: Terminated
Initiated: 2007-01-05
Posted: 2007-01-25
Terminated: 2008-05-01
Recalling firm: Cook Incorporated
Product: Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: Lack of assurance of sterility, as the packages may not have been sealed.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
Quantity in commerce: 4
Distribution: Massachusetts, Maine, New Hampshire and Puerto Rico.
Product codes and lots: Lot U1546391.

Product code FED

K043418Class IICook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. / cleared 2005-03-31

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)