Date Initiated by Firm |
June 08, 2010 |
Date Posted |
September 29, 2010 |
Recall Status1 |
Terminated 3 on February 29, 2012 |
Recall Number |
Z-2612-2010 |
Recall Event ID |
56413 |
Product Classification |
Cardioplegia Delivery Tube Sets - Product Code DTR
|
Product |
Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501 |
Code Information |
Lots: MD22 MD29 ME19 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Corporation 125 Blue Ball Road Elkton MD 21921-5315
|
For Additional Information Contact |
Mike Silvestri 410-392-7102
|
Manufacturer Reason for Recall |
Medical device vent port may be occluded and prevent delivery of priming fluid.
|
FDA Determined Cause 2 |
Equipment maintenance |
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. |
Quantity in Commerce |
352 kits |
Distribution |
The products were distributed nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|