Recall Z-1661-2013— DJO, LLC

Name: FDA recall Z-1661-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by DJO, LLC, initiated 2013-05-28, terminated 2014-02-13. It names one FDA 510(k) clearance: K091700. Product: 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: 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)..

Recalling firm: DJO, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2014-02-13
Firm location: Vista, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K091700 — AIRCAST VENAFLOW ELITE SYSTEMDjo, LLC·cleared 2009-07-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.