Device product
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0039-2015
Product summary
- Event
- Event 69146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))
- Official record key
device-enforcement:Z-0039-2015
Official wording
Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Code information: Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067
Distribution pattern: Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.
Derived failure modes
-
Unknown
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.