Recall Z-1911-2021— Exact Medical Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by Exact Medical Manufacturing, Inc., initiated 2021-04-29, terminated 2022-05-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N. Reason: No 510k for the product to be used in a natural or surgical opening to the body.
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-29
- Terminated
- 2022-05-26
- Firm location
- Lancaster, NY, United States
Product description
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Reason for recall
No 510k for the product to be used in a natural or surgical opening to the body
Data sourced from openFDA. This site is unofficial and independent of the FDA.