Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080.
FDA Recall Z-0181-06 · Posted 2005-11-23
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Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDWF
Date Initiated2005-10-19
Date Terminated2006-03-10
Product Quantity48
Reason for Recall
The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
Firm Action
Consignees were notified via telephone, and a recall letter dated 10/19/05 sent to each consignee, beginning on 10/18/05. International affiliates were notified via email.
Root Cause
Other
Distribution Pattern
California, Indiana, Missouri, Brazil and Germany.
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.
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