Z-0896-2008

Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA...

Name: Z-0896-2008 Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA...
Creator: Cook, Inc.
Published: 2007-12-07
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-12-07 / Terminated / root cause: packaging

FDA source

Cook, Inc. began a recall of Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long... on 2007-12-07. The reason FDA records is "Packaging Problem: The peel-away sheath does not peel uniformly or completely". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0896-2008
Status: Terminated
Initiated: 2007-12-07
Posted: 2008-04-16
Terminated: 2008-04-15
Recalling firm: Cook Incorporated
Product: Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
Product code: DYB Introducer, Catheter
Reason for recall: Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Root cause tag: packaging
FDA 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 in commerce: 1,881 of total products
Distribution: Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product codes and lots: Lot Numbers: F2114474 and F2120414.

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)