Recall Z-2243-2024— WOM World Of Medicine AG

Name: FDA recall Z-2243-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-24

Class II · Ongoing

Class II FDA medical device recall by WOM World Of Medicine AG, initiated 2024-05-24. It names one FDA 510(k) clearance: K062380. Product: 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. Reason: Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery.

Recalling firm: WOM World Of Medicine AG
Classification: Class II
Status: Ongoing
Initiated: 2024-05-24
Firm location: Ludwigsstadt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K062380 — FLOSIMPLE ARTHROSCOPY PUMP A120W.O.M. World of Medicine AG·cleared 2006-12-14

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

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

Reason for recall

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

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