| 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-1357-04 |
Recall Event ID |
29475 |
Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product | Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, steerable stylet, smooth balloon; catalog number 7271. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
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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 |
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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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