Recall Z-1041-2017 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
| Date | Nov 11, 2016 |
| Status | Open, Classified |
| Reason | Lack of 510k clearance for design modification. |
| Root cause | No Marketing Application |
| Action | On letter sent to all their consignees, Smith & Nephew asked to the consignees to removed all existing Renasys Go NPWT Pumps and returned following the instructions on the letter and also removed the affected power supply units identified on the recall letter. Each consignee needs to complete the Acknowledge |
| Quantity | 15,960 units in the US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083375 | RENASYS GO NEGATIVE PRESSURE WOUND THERAPY Smith & Nephew, Inc., Feb 25, 2009 |