Renasys EZ PLUS recall: Labeling Error
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Why was Renasys EZ PLUS recalled?
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: 66800912 - 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
- Product
- Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
- Recalling firm
- Smith & Nephew Inc.
- Quantity
- 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.
- Recall date
- March 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)