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Terminated

Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences

FDA Recall Z-1091-06 · Posted 2006-06-09

Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2006-04-18
Date Terminated2008-06-11
Product Quantity190 units (Domestic), 800 units (Foreign).

Reason for Recall

Due to potential embrittlement of the plastic 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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K831769VARIOUS CARDIOVASCULAR SURGICAL DEVICEResearch Industries Corp. · 1983-08-12

Official Source

View FDA Recall →

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

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