| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
July 07, 2004 |
| Date Posted |
August 17, 2004 |
| Recall Status1 |
Terminated 3 on October 26, 2004 |
| Recall Number |
Z-1347-04 |
| Recall Event ID |
29475 |
| 510(K)Number |
K915193A
|
| Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
|
| Product |
Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet, ribbed balloon, temperature monitor; catalog number 4429. |
| Code Information |
All lots. |
Recalling Firm/
Manufacturer |
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
|
| For Additional Information Contact |
Brian L. Dawson
800-262-7866 Ext. 6066
|
Manufacturer Reason
for Recall |
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004. |
| Distribution |
United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales. |
| 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.
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