• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Terumo perfusion cannulae

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Recall
Terumo perfusion cannulae
see related information
Date Posted February 27, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-0544-2007
Recall Event ID 37104
Premarket Notification
510(K) Number
K930620 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - 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, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = C.R. BARD, INC.
-
-