FDA-Device2013-07-10Class II
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.
DJO, LLC
Hazard
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).
Sold states
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.
Affected count
2491
Manufactured in
1430 Decision St, N/A, Vista, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1661-2013Don't want to check this manually?
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