FDAFDA · Food and drugs·Recall number Z-1596-2024
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
Published April 24, 2024 · Recall initiated: March 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew Medical, Ltd.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Lot
- GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.