| Class 2 Device Recall Maximum Pelvic Trainer | |
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
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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
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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 |
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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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