Terminated

Maximum Pelvic Trainer (MPT)

FDA Recall Z-2087-2019 · Posted None

Recalling FirmRalston Group

Recall StatusTerminated

Product CodeHIR

Date Initiated2019-07-12

Date Terminated2022-04-15

Product Quantity534 units

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.

Firm Action

Ralston Group notified customers on about 07/12/2019 via "IMPORTANT VOLUNTARY: MEDICAL DEVICE RECALL" email. Customers were advised that the device was incorrectly registered with the FDA and is therefore considered adulterated and misbranded if left on the market. Processes and documentation regarding the manufacture of this device were not adequately maintained. Also, clinical trials and claims concerning the effectiveness of the MPT were not evaluated by the FDA. Instructions included to immediately examine inventory for affected product, discontinue use/distribution, and quarantine al affected product. Customers were requested to complete the provided MEDICAL DEVICE RECALL RETURN RESPONSE to confirm receipt and understanding, and arrange for return of all affected product by contacting customer service at [email protected] or call 1-800-867-3726, Monday -Friday 8 AM 5 PM Central Time. Also customers were instructed to notify customers if the product was further distributed.

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.