Device 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
Z-2243-2024
Product summary
- Event
- Event 94749
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1700 units
- Official record key
device-enforcement:Z-2243-2024
Official wording
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
Code information: UDI: 04056702003678 Lot Numbers: 4030902, 4030903
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery