Recalls / —

—#25210

Product

COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT

FDA product code

DYB — Introducer, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

All lots on the market as of 11/25/2002.

Why it was recalled

The tip of the stiffened cannula might break during use and remain in the patient.

Root cause (FDA determination)

Other

Action the firm took

Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.

Recalling firm

Firm

Cook, Inc.

Address

750 Daniels Way P.O. Box 489, Bloomington, Indiana 47402-0489

Distribution

Distribution pattern

United States, Brazil, Canada, Dominican Republic and Israel.

Timeline

Recall initiated

2002-11-25

Posted by FDA

2003-02-28

Terminated

2003-03-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25210. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.