Reported Aug 7, 2019 · Terminated
Maximum Pelvic Trainer (MPT)
Ralston Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ralston Group · 656 Lake Lanier Rd · Selma, AL · 36701-3820
Is this the product you have?
- Maximum Pelvic Trainer (MPT)
- Lot codes and dates
- Item CodeOBS MPT M.P.T
- Lot Numbers
151015008160104003160411001160523009160525002160921003161027002161128003170111002170503002170626008171120003180321003180723008181217005
- Amount recalled
- 534 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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