Recall Z-1067-2014 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew Inc.
Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
| Date | Feb 21, 2014 (initiated Nov 14, 2013) |
| Status | Terminated |
| Reason | Modification of the bacterial overflow guard (filter) and related changes to product labeling. |
| Root cause | Device Design |
| Action | 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 N |
| 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, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.