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

Class 2 Device Recall Maquet Coronary Perfusion Cannulae with Balloon Tip

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


New Search Back to Search Results
 Class 2 Recall
Maquet Coronary Perfusion Cannulae with Balloon Tip
see related information
Date Posted August 31, 2009
Recall Status1 Open
Recall Number Z-1869-2009
Recall Event ID 52663
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.
Code Information Manufacturing lot numbers 272809 to 278615 and 70000241 to 70024294, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.
Recalling Firm/
Manufacturer
Maquet Cardiovascular
170 Baytech Dr
San Jose, California 95134-2302
Manufacturer Reason
for Recall
Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.
Quantity in Commerce 2,226 devices
Distribution Nationwide distribution.
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.
-
-