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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Coronary Perfusion Cannulae with Balloon Tip

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  Class 2 Device Recall Maquet Coronary Perfusion Cannulae with Balloon Tip see related information
Date Initiated by Firm May 19, 2009
Date Posted August 31, 2009
Recall Status1 Terminated 3 on December 21, 2010
Recall Number Z-1869-2009
Recall Event ID 52663
Product Classification Coronary Perfusion Cannulae - 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 CA 95134-2302
For Additional Information Contact
408-635-6874
Manufacturer Reason
for Recall		 Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.
FDA Determined
Cause 2		 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 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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