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Terminated

Aortic Perfusion Cannula with Metal Tip, 22 Fr. x 23 cm., Edwards Lifesciences

FDA Recall Z-1095-06 · Posted 2006-06-09

Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2006-04-18
Date Terminated2008-06-11
Product Quantity30 units (Domestic), 30 units (Foreign)

Reason for Recall

Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.

Firm Action

Consignees were notified by letter and visit beginning 04/18/2006.

Root Cause

Other

Distribution Pattern

CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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