FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Research Medical, Inc.: Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
- Recall number
- Z-1893-2008
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Product
- Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
- Status
- Terminated
- Initiated
- 2008-02-25
- Posted
- 2008-09-11
- Terminated
- 2008-09-16
- Reason
- Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
- Root cause
- Process control
- Action
- Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.
- Quantity
- 25 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot 58458668
- 510(k) numbers
- ["K033464","K891576"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1713910
- Firm city
- Midvale
- Firm state
- UT
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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