Z-1912-2021 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
- 9680 units
Product Description
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
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: 1912E127 2003E794 2002E132 2003E801 2004E024 2004E514 2009E127 2008E357 2009E467 2009E250 2011E108 2012E100 2012E104