Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM l

FDA device recall Z-0898-2008 · posted 2008-04-16 · Terminated

Recall details

Recalling firm

Cook, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

DYB

Quantity affected

1,881 of total products

Distribution

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

Date initiated

2007-12-07

Date posted

2008-04-16

Date terminated

2008-04-15

Location

Bloomington, IN