Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Reported: March 5, 2014 Initiated: November 14, 2013 #Z-1068-2014
Product Description
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Reason for Recall
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Details
- Recalling Firm
- Smith & Nephew Inc.
- Units Affected
- 6,871,375 canisters
- Distribution
- Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
- Location
- Saint Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System. Recalled by Smith & Nephew Inc.. Units affected: 6,871,375 canisters.
Why was this product recalled? ▼
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1068-2014.
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