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Recall Observatory FDA recall evidence

Device product

Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

Z-1067-2014

November 14, 2013

Class II

Product summary

Firm
Smith & Nephew Inc.
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

    reason.no_named_rule · v1.0.0

    Modification of the bacterial overflow guard (filter) and related changes to product labeling.