| Date Initiated by Firm | August 08, 2003 |
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| Date Posted | August 29, 2003 |
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| Recall Status1 |
Terminated 3 on March 11, 2004 |
| Recall Number | Z-1193-03 |
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| Recall Event ID |
27041 |
| 510(K)Number | K925442 |
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| Product Classification |
unknown device name - Product Code 74DWF
|
| Product | Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579 |
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| Code Information |
Lots 1203930 and 1203940. |
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Systems Corp
6200 Jackson Rd.
Ann Arbor MI 48103
|
| For Additional Information Contact |
800-521-2818 |
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Manufacturer Reason
for Recall | Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility. |
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FDA Determined
Cause 2 | Other |
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| Action | Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo. |
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| Distribution | United States, Canada, Chile, China, Germany and Japan. |
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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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| 510(K) Database | 510(K)s with Product Code = 74DWF
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