Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff
FDA device recall Z-1213-04 · posted 2004-07-27 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 2
- Distribution
- Nationwide, Canada, Denmark and Japan.
- Date initiated
- 2004-06-10
- Date posted
- 2004-07-27
- Date terminated
- 2004-11-01
- Location
- Bloomington, IN
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