Recall Z-0615-2013 ยท JOW Sleeve, Limb, Compressible
Arjo, Inc. dba ArjoHuntleigh
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.
| Date | Dec 27, 2012 (initiated Dec 10, 2012) |
| Status | Terminated |
| Reason | The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. |
| Root cause | 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 | 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, Orego |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 Huntleigh Healthcare, Inc., Mar 26, 2002 |