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Class 2 Device Recall |
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| Date Initiated by Firm |
August 08, 2003 |
| Date Posted |
August 29, 2003 |
| Recall Status1 |
Terminated 3 on March 11, 2004 |
| Recall Number |
Z-1192-03 |
| Recall Event ID |
27041 |
| 510(K)Number |
K925442
|
| Product Classification |
unknown device name - Product Code 74DWF
|
| Product |
Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578 |
| Code Information |
Lot 1197400 |
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.
|
FDA Determined
Cause 2 |
Other |
| 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. |
| 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 and Original Applicant = 3M HEALTH CARE, SARNS
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