Reported Mar 5, 2014 · Terminated
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Smith & Nephew 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: Smith & Nephew Inc. · 970 Lake Carillon Dr · Saint Petersburg, FL · 33716-1130
Is this the product you have?
- Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
- Lot codes and dates
- Product code66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299
- Amount recalled
- 6,871,375 canisters
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
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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