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Recall Observatory FDA recall evidence

Device product

RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) 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-0041-2015

July 18, 2014

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 69146
Status
Terminated
Classification
Class II
Quantity
45,466
Official record key
device-enforcement:Z-0041-2015

Official wording

Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

Code information: Item 66800912 Lot # M400071

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

    reason.no_named_rule · v1.0.0

    RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.