—#67174

Product

Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lot Numbers: 1923714, 1923715, 1923718, 1923719, 1923721, 1923722, 1923723, 1928888, 1928889, 1928891, 1928892, 1928893, 1928894, 1928895, 1928896, 1928897, 1935086, 1935087, 1935089, 1935090, 1935095, 1958841, 1958843, 1958844, 1958847, 1958848, 1958849, 1958850, 1958851 and 1972150.

Why it was recalled

Packaging Problem: The peel-away sheath does not peel uniformly or completely.

Root cause (FDA determination)

Package design/selection

Action the firm took

Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.

Timeline

Recall initiated: 2007-12-07
Posted by FDA: 2008-04-16
Terminated: 2008-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67174. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.