RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it
FDA device recall Z-1596-2024 · posted 2024-04-18 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew Medical, Ltd.
- 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
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OMP
- Quantity affected
- 6895 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Date initiated
- 2024-03-11
- Date posted
- 2024-04-18
- Location
- Hull, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Renasys Edge (66803126) (K223041) | Smith & Nephew Medical Limited | 2022-11-22 |