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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 FirmAugust 08, 2003
Date PostedAugust 29, 2003
Recall Status1 Terminated 3 on March 11, 2004
Recall NumberZ-1190-03
Recall Event ID 27041
Product Classification unknown device name - Product Code 74DWF
ProductSarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
Code Information Lots 1200590 and 1200600.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd.
Ann Arbor MI 48103
For Additional Information Contact
800-521-2818
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
ActionUrgent 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.
DistributionUnited States, Canada, Chile, China, Germany and Japan.
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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