Recall Z-1067-2014
Smith & Nephew Inc. · initiated November 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Codes / lots: 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
Reason for recall
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
FDA-determined cause: Device Design
Action taken
The correction strategy is as follows: " An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery. " A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees. " US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013. " The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market. " Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..
Details
- Recall number
- Z-1067-2014
- Initiated
- November 14, 2013
- Posted by FDA
- February 21, 2014
- Terminated
- August 4, 2014
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 6,799,140 canisters EZ & EZ PLUS
- Distribution
- 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…
- Recalling firm
- Smith & Nephew Inc., Saint Petersburg, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1068-2014 Class II | Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy…Modification of the bacterial overflow guard (filter) and related changes to product labeling. | 11/14/2013Terminated |