Z-1917-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- May 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51300 units
Product Description
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
Reason for Recall
No 510k for the product to be used in a natural or surgical opening to the body
Distribution Pattern
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Code Information
Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404