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Terminated

Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35. Cook Inc., Bloomington, IN 47404

FDA Recall Z-0899-2008 · Posted 2008-04-16

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2007-12-07
Date Terminated2008-04-15
Product Quantity1,881 of total products

Reason for Recall

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

Firm Action

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.

Root Cause

Package design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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