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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns arterial cannula

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 Class 2 Device Recall Sarns arterial cannulasee related information
Date Initiated by FirmSeptember 12, 2005
Date PostedNovember 26, 2005
Recall Status1 Terminated 3 on March 22, 2006
Recall NumberZ-0200-06
Recall Event ID 33506
510(K)NumberK771499 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductTerumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
Code Information Lots 0385384 and 0386969.
FEI Number 1828100
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-262-3304 Ext. 6066
Manufacturer Reason
for Recall		There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
FDA Determined
Cause 2		Other
ActionConsignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05.
Quantity in Commerce2520
DistributionNationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate.
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.
510(K) Database510(K)s with Product Code = DWF
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