Device product
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
Z-1596-2024
Product summary
- Event
- Event 94248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6895 units
- Official record key
device-enforcement:Z-1596-2024
Official wording
Reason: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Code information: GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter