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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.

FDA Recall Z-1661-2013 · Posted 2013-07-03

Recalling FirmDJO, LLC
Recall StatusTerminated
Product CodeJOW
Date Initiated2013-05-28
Date Terminated2014-02-13
Product Quantity2491

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).

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091700AIRCAST VENAFLOW ELITE SYSTEMDjo, LLC · 2009-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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