Date Initiated by Firm | February 25, 2003 |
Date Posted | March 20, 2003 |
Recall Status1 |
Terminated 3 on June 06, 2003 |
Recall Number | Z-0664-03 |
Recall Event ID |
25714 |
Product Classification |
Heat-Exchanger, Cardiopulmonary Bypass - Product Code DTR
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Product | Sarns MP4 Cardioplegia Sets; catalog number 15501. |
Code Information |
Lot 322125 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd. Ann Arbor MI 48103
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For Additional Information Contact | 800-521-2818 |
Manufacturer Reason for Recall | There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery. |
FDA Determined Cause 2 | Other |
Action | Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers. |
Quantity in Commerce | 300 |
Distribution | United States |
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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