Reported Oct 15, 2014 · Terminated
RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are…
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/ RENASYS EZ Plus 800 mL
- canister with Solidifier Product UsageRENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT)
- Lot codes and dates
- Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124
- Amount recalled
- 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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