FDA Enforcement
Class II
Ongoing
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Recall: Z-1596-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1596-2024
- Event ID
- 94248
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smith & Nephew Medical, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 11, 2024
- Classification Date
- April 18, 2024
- Address
- 101 Hessle Road, Hull, N/A, United Kingdom
Description
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Reason
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Code Info
GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Quantity
6895 units