Z-0368-06

Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus...

Name: Z-0368-06 Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus...
Creator: Cook, Inc.
Published: 2005-09-26
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2005-09-26 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end... on 2005-09-26. The reason FDA records is "The coil is 20 centimeters in length, but the label states the length is 20 millimeters". 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-0368-06
Status: Terminated
Initiated: 2005-09-26
Posted: 2006-01-10
Terminated: 2006-01-10
Recalling firm: Cook Incorporated
Product: Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
Product code: KRD Device, Vascular, For Promoting Embolization
Reason for recall: The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via telephone and recall letter dated September 26, 2005.
Quantity in commerce: 242
Distribution: Delaware, New York and Pennsylvania.
Product codes and lots: Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165.

Product code KRD

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)