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U.S. Department of Health and Human Services

Class 2 Device Recall Flowtron Trio Pump

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 Class 2 Recall
Flowtron Trio Pump
see related information
Date Posted December 27, 2012
Recall Status1 Open
Recall Number Z-0615-2013
Recall Event ID 63857
Premarket Notification
510(K) Number
K010744 
Product Classification Sleeve, Limb, Compressible - Product Code JOW
Product Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
Code Information Model 512003, all serial numbers
Recalling Firm/
Manufacturer
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Brenda Ammonette
800-323-1245
Manufacturer Reason
for Recall
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
FDA Determined
Cause 2
PREMARKET APPROVAL: No Marketing Application
Action ArjoHuntleigh sent an Urgent Field Correction Recall letters dated December 10, 2012, to all affected customers, informing the accounts that the pumps were marketed without proper FDA approval, and that ArjoHuntleigh is removing the pumps from the market and replacing them with a suitable alternative. The accounts were requested to disseminate the information to all organizations where the devices may have been transferred, and to complete the Customer Response Form and return it to ArjoHuntleigh by mail, fax or e-mail. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.
Quantity in Commerce 2,859 unts
Distribution USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming.
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 = JOW and Original Applicant = HUNTLEIGH HEALTHCARE, INC.
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