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 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54.
- Recall number
- Z-1185-04
- 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 12 mm - usable length 54mm - delivery system 14 FR; Catalog no. TFLE-12-54.
- 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
- 60
- Distribution
- Nationwide, Canada, Denmark and Japan.
- Lot, serial or model codes
- Lots 1359073, 1359079, 1359064, 1359076, F1550328, F1550329, F1550330, F1549761, F1552568, F1552569, F1552570, F1552571, F1554548, F1556419, F1556420, F1554547, F1555390, F1556418, F1556421, F1556422, F1559022, F1559023, F1559024, F1559025, F1559026, F1564339, F1564144, F1564145, F1564146, F1564147, F1564148, F1564149, F1564150, F1564136, F1561373, F1561374, F1561375, F1561376, F1564337, F1564338, F1564340, F1564341, F1565723, F1565724, F1565725, F1565726, F1565727, F1565786, F1565787, F1565788, F1565789, F1565790, 1359080, 1359074, 1354034, 1359067, 1363354, 1357534, 1357533 and 1359081.
- 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