Cook, Inc. Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 105mm - delivery system 14 FR;Catalog no. TFLE-10-105. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 10 mm - usable length 105mm - delivery system 14 FR;Catalog no. TFLE-10-105.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lots F1564137, F1565736, F1569307, F1569229, F1572912 and 1364190.
Products Sold
Lots F1564137, F1565736, F1569307, F1569229, F1572912 and 1364190.
Cook, Inc. is recalling Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg due to Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer durin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
Recommended Action
Per FDA guidance
The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.
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