Duraflo Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm, Edwards Lifesciences
FDA Recall Z-1092-06 · Posted 2006-06-09
Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2006-04-18
Date Terminated2008-06-11
Product Quantity50 units (Domestic)
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.