Device product
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Z-1067-2014
Product summary
- Event
- Event 66893
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,799,140 canisters EZ & EZ PLUS
- Official record key
device-enforcement:Z-1067-2014
Official wording
Reason: Modification of the bacterial overflow guard (filter) and related changes to product labeling.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
Modification of the bacterial overflow guard (filter) and related changes to product labeling.