Medical device recalls Moderate risk

WOM World Of Medicine AG recalls WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries.…

Recall date
May 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2243-2024
FDA classification
Class II
Brand / firm
WOM World Of Medicine AG
Sold / distributed
US Nationwide distribution.

Why it was recalled

Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01

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