—#42300

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.

FDA product code: KRD — Device, Vascular, For Promoting Embolization
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165.

Why it was recalled

The coil is 20 centimeters in length, but the label states the length is 20 millimeters.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via telephone and recall letter dated September 26, 2005.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Delaware, New York and Pennsylvania.

Timeline

Recall initiated: 2005-09-26
Posted by FDA: 2006-01-10
Terminated: 2006-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.