Recall Z-2087-2019— Ralston Group

Name: FDA recall Z-2087-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-12

Class II · Terminated

Class II FDA medical device recall by Ralston Group, initiated 2019-07-12, terminated 2022-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Maximum Pelvic Trainer (MPT). Reason: The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device..

Recalling firm: Ralston Group
Classification: Class II
Status: Terminated
Initiated: 2019-07-12
Terminated: 2022-04-15
Firm location: Selma, AL, United States

Product description

Maximum Pelvic Trainer (MPT)

Reason for recall

The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.