Z-2243-2024 Class II Ongoing
FDA device recall Z-2243-2024 was initiated by WOM World Of Medicine AG on May 24, 2024 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 1700 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2024
- Initiation Date
- May 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1700 units
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
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: 04056702003678 Lot Numbers: 4030902, 4030903