Recall Z-0040-2015 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew, Inc.
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).
| Date | Oct 8, 2014 (initiated Jul 18, 2014) |
| Status | Terminated |
| Reason | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. |
| Root cause | Device Design |
| Action | 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. |
| 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, Shangha |
| FDA record | Open on fda.gov |