Z-0436-03

COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-NT

Name: Z-0436-03 COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-NT
Creator: Cook, Inc.
Published: 2002-11-25
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2002-11-25 / Terminated

FDA source

Cook, Inc. began a recall of COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-NT on 2002-11-25. The reason FDA records is "The tip of the stiffened cannula might break during use and remain in the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0436-03
Status: Terminated
Initiated: 2002-11-25
Posted: 2003-02-28
Terminated: 2003-03-21
Recalling firm: Cook Incorporated
Product: COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-NT
Product code: DYB Introducer, Catheter
Reason for recall: The tip of the stiffened cannula might break during use and remain in the patient.
FDA root cause: Other
Action: Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
Quantity in commerce: 832
Distribution: United States, Brazil, Canada, Dominican Republic and Israel.
Product codes and lots: All lots on the market as of 11/25/2002.

Product code DYB

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)