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, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lot Numbers: F2143720, F2143731, F2144828, F2147203, F2147788 and F2148621.
Products Sold
Lot Numbers: F2143720, F2143731, F2144828, F2147203, F2147788 and F2148621.
Cook, Inc. is recalling Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: due to Packaging Problem: The peel-away sheath does not peel uniformly or completely.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026