FDA Medical Device Recalls (openFDA)
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 24 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-24-71.
- Recall number
- Z-1210-04
- Recalling firm
- Cook, Inc.
- Product
- Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-24-71.
- Status
- Terminated
- Initiated
- 2004-06-10
- Posted
- 2004-07-27
- Terminated
- 2004-11-01
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 28
- Distribution
- Nationwide, Canada, Denmark and Japan.
- Lot, serial or model codes
- Lots F1573048, F1571074, F1561902, F1569266, F1565685, F1569268, F1565686, F1565687, F1565689, F1573057, F1573058, F1573059, F1573060, F1573061, F1573049, F1573050, F1565688, F1571072, F1571073, F1571075, F1561419, F1573052, F1575274, F1575275, F1575365, F1575366, F1575367 and F1575368.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020018"]
- Product code
- MIH
- 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