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Recall Observatory FDA recall evidence

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

March 11, 2024

Class II

Product summary

Firm
Smith & Nephew Medical, Ltd.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter