Z-1809-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- April 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85
Product Description
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Reason for Recall
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Distribution Pattern
Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
Code Information
All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860