| Date Initiated by Firm | June 08, 2010 |
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| Date Posted | September 29, 2010 |
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| Recall Status1 |
Terminated 3 on February 29, 2012 |
| Recall Number | Z-2613-2010 |
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| Recall Event ID |
56413 |
| Product Classification |
Cardioplegia Delivery Tube Sets - Product Code DTR
|
| Product | Sarns Cardioplegia Set CPLG BLD MP4 4:1
No recirculation, Item # 16010 |
|---|
| Code Information |
Lot Numbers: MD22, and ME19, |
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Corporation
125 Blue Ball Road
Elkton MD 21921-5315
|
| For Additional Information Contact | Mike Silvestri
410-392-7102 |
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Manufacturer Reason
for Recall | Medical device vent port may be occluded and prevent delivery of priming fluid. |
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FDA Determined
Cause 2 | Equipment maintenance |
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| 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. |
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| Quantity in Commerce | 160 kits |
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| Distribution | The products were distributed nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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