Recall Z-2610-2010
Terumo Cardiovascular Corporation · initiated June 8, 2010
Product
Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375
Codes / lots: Lot numbers: MD15, MD15A, MD22, MD29, MD29A, ME19, and ME26A
Reason for recall
Medical device vent port may be occluded and prevent delivery of priming fluid.
FDA-determined cause: Equipment maintenance
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.
Details
- Recall number
- Z-2610-2010
- Initiated
- June 8, 2010
- Posted by FDA
- September 29, 2010
- Terminated
- February 29, 2012
- Product code
- DTR – Heat-Exchanger, Cardiopulmonary Bypass
- Quantity
- 1682 kits
- Distribution
- The products were distributed nationwide.
- Recalling firm
- Terumo Cardiovascular Corporation, Elkton, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2611-2010 | Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2612-2010 | Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2613-2010 | Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2614-2010 | Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2615-2010 | Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part…Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2616-2010 | Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component…Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |
| Z-2617-2010 | Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03Medical device vent port may be occluded and prevent delivery of priming fluid. | 06/08/2010Terminated |