Reported Mar 12, 2014 · Terminated
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage…
Kci USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KCI USA, INC. · 12930 IH 10 West · San Antonio, TX · 78249
Is this the product you have?
- PRE1001Prevena
- Peel and Place System Kit Product UsageThe Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy
- Lot codes and dates
Kit Lot #'s 2363893236789023688762368877237987023828692389874239788424068892410933241186624178792423890
- Amount recalled
- 20,850 units total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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