Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 26mm, B=141mm, C=111mm, D=
FDA device recall Z-0512-05 · posted 2005-02-03 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
- Action taken
- Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIH
- Distribution
- Nationwide and Canada.
- Date initiated
- 2004-12-20
- Date posted
- 2005-02-03
- Date terminated
- 2005-12-02
- Location
- Bloomington, IN
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