Z-0674-06

Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540

Name: Z-0674-06 Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540
Creator: Cook Urological, Inc.
Published: 2006-03-01
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2006-03-01 / Terminated / root cause: labeling and UDI

FDA source

Cook Urological, Inc. began a recall of Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540 on 2006-03-01. The reason FDA records is "Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device...". 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-0674-06
Status: Terminated
Initiated: 2006-03-01
Posted: 2006-03-23
Terminated: 2008-07-01
Recalling firm: Cook Incorporated
Product: Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.
Product code: FAD Stent, Ureteral
Reason for recall: Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.
Quantity in commerce: 1300
Distribution: Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.
Product codes and lots: All units.

Product code FAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)