Recall Z-1661-2013 ยท JOW Sleeve, Limb, Compressible
DJO, LLC
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
| Date | Jul 3, 2013 (initiated May 28, 2013) |
| Status | Terminated |
| Reason | DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire). |
| Root cause | Device Design |
| Action | DJO sent a Customer Notification letter dated May 28, 2013 to Domestic customers via USPS certified return receipt and to International customers via UPS on June 14, 2013. The Customer Notification informed customers of the product safety issue, product description, and instructions to follow. DJO plans to install replacement batteries at no charge. For questions contact your local DJO Customer Service Representative. |
| Quantity | 2491 |
| Distribution | Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091700 | AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC, Jul 9, 2009 |