Z-1597-2024 Class II Ongoing
FDA device recall Z-1597-2024 was initiated by Smith & Nephew Medical, Ltd. on March 11, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 675 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 675 units
Product Description
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
Code Information
GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549