FDA recall Z-1597-2024

Product

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

Worldwide distribution - US Nationwide and the countries of Canada, Chile.

Key facts

Status

Ongoing

Initiation date

2024-03-11

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hull, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2024