FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 132mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-24-132.
- Recall number
- Z-1168-04
- Recalling firm
- Cook, Inc.
- Product
- Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths contralateral limb 132mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-24-132.
- 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
- 1
- Distribution
- Nationwide, Canada, Denmark and Japan.
- Lot, serial or model codes
- Lot F1571627.
- 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