Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
FDA device recall Z-2613-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Corporation
- Reason for recall
- Medical device vent port may be occluded and prevent delivery of priming fluid.
- Action taken
- 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
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 160 kits
- Distribution
- The products were distributed nationwide.
- Date initiated
- 2010-06-08
- Date posted
- 2010-09-29
- Date terminated
- 2012-02-29
- Location
- Elkton, MD
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