Z-1907-2021 Class II Terminated
FDA device recall Z-1907-2021 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: 8800 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
- 8800 units
Product Description
Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
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: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103