Recall Z-0040-2015
Smith & Nephew, Inc. · initiated July 18, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124
Reason for recall
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
FDA-determined cause: Device Design
Action taken
Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.
Details
- Recall number
- Z-0040-2015
- Initiated
- July 18, 2014
- Posted by FDA
- October 8, 2014
- Terminated
- August 5, 2015
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 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.
- Recalling firm
- Smith & Nephew, Inc., Saint Petersburg, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0039-2015 Class II | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ…RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | 07/18/2014Terminated |
| Z-0041-2015 Class II | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage:…RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | 07/18/2014Terminated |