Vision Hollow Fiber Oxygenator
FDA Recall Z-0780-03 · Posted 2003-04-22
Recalling FirmGish Biomedical Inc
Recall StatusTerminated
Date Initiated2003-03-31
Date Terminated2004-03-09
Product Quantity1749
Reason for Recall
Two reports of leakage.
Firm Action
The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
Root Cause
Other
Distribution Pattern
Nationwide, Austria, Canada, Japan, Saudi Arabia
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.