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Ralston Group recalls Maximum Pelvic Trainer (MPT)
Recalled August 7, 2019 · FDA recall Z-2087-2019 · Ralston Group
Hazard
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. · FDA Class II
Units
534 units
Sold at
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and PR.
Description
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.
Product
Maximum Pelvic Trainer (MPT)
Manufacturer(s)
Ralston Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →