FDA Medical Device Recalls (openFDA)
Cook, Inc.: Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
- Recall number
- Z-0897-2008
- Recalling firm
- Cook, Inc.
- Product
- Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
- Status
- Terminated
- Initiated
- 2007-12-07
- Posted
- 2008-04-16
- Terminated
- 2008-04-15
- Reason
- Packaging Problem: The peel-away sheath does not peel uniformly or completely.
- Root cause
- Package design/selection
- 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.
- Quantity
- 1,881 of total products
- Distribution
- Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
- Lot, serial or model codes
- Lot Number: F2143777.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28