FDA recall Z-2243-2024

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 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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-05-24

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ludwigsstadt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2024