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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 07, 2004
Date PostedAugust 17, 2004
Recall Status1 Terminated 3 on October 26, 2004
Recall NumberZ-1357-04
Recall Event ID 29475
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductSarns 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
For Additional Information ContactBrian 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
ActionThe 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.
DistributionUnited 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 CycleTPLC 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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