Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501
FDA Recall Z-2612-2010 · Posted 2010-09-29
Recalling FirmTerumo Cardiovascular Corporation
Recall StatusTerminated
Product CodeDTR
Date Initiated2010-06-08
Date Terminated2012-02-29
Product Quantity352 kits
Reason for Recall
Medical device vent port may be occluded and prevent delivery of priming fluid.
Firm Action
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
Root Cause
Equipment maintenance
Distribution Pattern
The products were distributed nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.