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U.S. Department of Health and Human Services

Class 2 Device Recall Maximum Pelvic Trainer

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  Class 2 Device Recall Maximum Pelvic Trainer see related information
Date Initiated by Firm July 12, 2019
Create Date July 26, 2019
Recall Status1 Terminated 3 on April 15, 2022
Recall Number Z-2087-2019
Recall Event ID 83328
Product Classification Perineometer - Product Code HIR
Product Maximum Pelvic Trainer (MPT)
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   
Recalling Firm/
Manufacturer		 Ralston Group
656 Lake Lanier Rd
Selma AL 36701-3820
For Additional Information Contact Gail Ralston
334-875-2298
Manufacturer 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.
FDA Determined
Cause 2		 Other
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 info@bestforlife.com 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.
Quantity in Commerce 534 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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