Recall Z-1597-2024
Smith & Nephew Medical, Ltd. · initiated March 11, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Codes / lots: GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
Reason for recall
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
FDA-determined cause: Under Investigation by firm
Action taken
Smith & Nephew Medical Ltd. issued Urgent Medical Device Recall Notice R-2024-02 on March 11, 2024 via overnight mail. Letter states reason for recall, health risk and action to take: Based on the regulatory classification and degree of hazard, this field action extends to the retail level. Therefore, it is not required to communicate this notice to the patient at the consumer level. If your customer contacts you regarding a pump failure: 1. Contact S+N Clinical Hotline (800-876-1261) with any questions. 2. Please ensure you provide a replacement as soon as possible. Replacement Stock. Smith+Nephew is supplying replacement stock quantities in parallel with this notice. Please contact AWM.returns.cr@smith-nephew.com if you have any questions. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Details
- Recall number
- Z-1597-2024
- Initiated
- March 11, 2024
- Posted by FDA
- April 18, 2024
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Recalling firm
- Smith & Nephew Medical, Ltd., Hull
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1596-2024 Class II | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit…Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and… | 03/11/2024Open, Classified |