VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention o
FDA device recall Z-1661-2013 · posted 2013-07-03 · Terminated
Recall details
- Recalling firm
- DJO, LLC
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- JOW
- Quantity 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
- Date initiated
- 2013-05-28
- Date posted
- 2013-07-03
- Date terminated
- 2014-02-13
- Location
- Vista, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRCAST VENAFLOW ELITE SYSTEM (K091700) | Djo, LLC | 2009-07-09 |