PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 10, 2013 Initiated: May 28, 2013 #Z-1661-2013

Product Description

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.

Reason for Recall

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).

Details

Recalling Firm
DJO, LLC
Units Affected
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 Kingdom and Venezula.
Location
Vista, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by DJO, LLC. Units affected: 2491.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1661-2013.