Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm. , Edwards Lifesciences
FDA device recall Z-1094-06 · posted 2006-06-09 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Research Medical, Inc.
- Reason for recall
- Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.
- Action taken
- Consignees were notified by letter and visit beginning 04/18/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 26 units (Domestic), 420 units (Foreign)
- Distribution
- CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
- Date initiated
- 2006-04-18
- Date posted
- 2006-06-09
- Date terminated
- 2008-06-11
- Location
- Midvale, UT
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