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U.S. Department of Health and Human Services

Class 3 Device Recall Terumo perfusion cannulae

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  Class 3 Device Recall Terumo perfusion cannulae see related information
Date Initiated by Firm December 07, 2006
Date Posted February 27, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-0544-2007
Recall Event ID 37104
510(K)Number K930620  
Product Classification arterial perfusion cannulae - Product Code DWF
Product Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351.
Code Information Lot 2119905, exp. October 2009.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-262-3304
Manufacturer Reason
for Recall		 The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
FDA Determined
Cause 2		 Other
Action Consignee was notified via telephone on 12/7/06 and returned the product.
Quantity in Commerce 10
Distribution Pennsylvania.
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.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = C.R. BARD, INC.
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