Z-2087-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- July 12, 2019
- Termination Date
- April 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 534 units
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.
Distribution Pattern
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.
Code Information
Item Code: OBS MPT M.P.T; Lot Numbers: 151015008, 160104003, 160411001, 160523009, 160525002, 160921003, 161027002, 161128003, 170111002, 170503002, 170626008, 171120003, 180321003, 180723008, 181217005