RENASYS EZ/ RENASYS EZ Plus 800 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).
Reported: October 15, 2014 Initiated: July 18, 2014 #Z-0040-2015
Product Description
RENASYS EZ/ RENASYS EZ Plus 800 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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))
- Distribution
- 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.
- Location
- Saint Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
RENASYS EZ/ RENASYS EZ Plus 800 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).. Recalled by Smith & Nephew, Inc.. Units affected: 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066)).
Why was this product recalled? ▼
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2014. Severity: Moderate. Recall number: Z-0040-2015.
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