Recall Z-1042-2017
Smith & Nephew, Inc. · initiated November 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, 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.
Codes / lots: Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
Reason for recall
Lack of 510k clearance for design modification.
FDA-determined cause: No Marketing Application
Action taken
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
Details
- Recall number
- Z-1042-2017
- Initiated
- November 11, 2016
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 15,960 units (US )
- Distribution
- Nationwide
- Recalling firm
- Smith & Nephew, Inc., Saint Petersburg, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1041-2017 Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for…Lack of 510k clearance for design modification. | 11/11/2016Open, Classified |