Recall Z-1597-2024— Smith & Nephew Medical, Ltd.

Name: FDA recall Z-1597-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-11

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Medical, Ltd., initiated 2024-03-11. It names one FDA 510(k) clearance: K223041. 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: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump.

Recalling firm: Smith & Nephew Medical, Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-11
Firm location: Hull, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K223041 — Renasys Edge (66803126)Smith & Nephew Medical Limited·cleared 2022-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.