Z-1909-2021 Class II Terminated
FDA device recall Z-1909-2021 was initiated by Exact Medical Manufacturing, Inc. on April 29, 2021 and is designated Class II. Reason for recall: No 510k for the product to be used in a natural or surgical opening to the body The recall status is terminated (terminated May 26, 2022). Affected quantity: 17545 units.
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
- 17545 units
Product Description
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
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: 1912E126 2002E133 2008E227 2008E226