Z-0039-2015 Class II Terminated
FDA device recall Z-0039-2015 was initiated by Smith & Nephew, Inc. on Jul 18, 2014 and is designated Class II. Reason for recall: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. The recall status is terminated (terminated Aug 5, 2015). Affected quantity: 19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913)).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 15, 2014
- Initiation Date
- Jul 18, 2014
- Termination Date
- Aug 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))
Product Description
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).
Reason for Recall
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
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.
Code Information
Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0039-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026