Recall Z-1504-2021
Merits Holdings Co. dba Merits Health Products, Inc. · initiated April 1, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Power Wheelchair
Codes / lots: Gemini PWC- Model Number: P301; Part No: P30111ARMU; Serial Numbers: MU200900398, MU200401050, MU200900415, MU200401058, MU200401064, MU200401069, MU200401067, MU200401060, MU200900417, MU200900410, MU200401059, MU200401063, MU200401068, MU200401062, MU200401056, MU200401065, MU200401055, MU200401051, MU200900404, MU200900409, MU200900399, MU200900416, MU200900405, MU200900407, MU200401061, MU200401066, MU200401054, MU200401052 Gemini PWC - Model Number: P301; Part No: P3017-ARMU; Serial Numbers: MU200700022, MU200800669, MU200700024, MU200800660, MU200800665, MU200800661, MU200800664, MU200800668, MU200800663, MU200700028, MU200700021, MU200800659, MU200800667, MU200800662, MU200700026, MU200700025, MU200700023, MU200700027 Gemini PWC - Model Number: P301; Part No: P3017-SBMU; Serial Numbers: MU200700036, MU200800671, MU200800672, MU200800675, MU200800678, MU200800674, MU200700033, MU200800676 Regal PWC Model Number: P310; Part No: P310A-ARMUB; Serial Numbers: MU200900199, MU200900881, MU200900890, MU200900204, MU200900246, MU200900247, MU200900208 Vision CF PWC Model Number: P322; Part No: P322A3ARMUB; Serial Numbers: MU200600861, MU200600524, MU200600850, MU200600529…
Reason for recall
Seat baseplate pin has broken in the field.
FDA-determined cause: Process change control
Action taken
A Recall notification letter titled, "MEDICAL DEVICE FIELD CORRECTION" was sent to consignees on 04/07/2021 via email and by certified mail on 04/16/2021. The firm stated they made phone call notifications on 04/01/2021. The letter instructs the consignee to Contact impacted customer using a personalized customer letter (template provided). The notification can be sent by mail, email or phone. (IF by phone, please keep a log of call. Date/Time/Result); replace the old seat plate with new one provided using the SOP provided. The field correction should take approximately 15 minutes to complete.; complete and return the Service and Repair Report (sent with new part), inspect the installation and note it on the appropriate Scooter or Power Chair Inspection Record provided; use the RA shipping label (sent with new part) and return old seat plate to Merits Health Products along with the Service and Repair Report (one filled out for each unit); and when all of the units in the possession of the consignee are finished, please return the completed Inspection Report/s to Merits by mail or email.
Details
- Recall number
- Z-1504-2021
- Initiated
- April 1, 2021
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 3054 units
- Distribution
- Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada
- Recalling firm
- Merits Holdings Co. dba Merits Health Products, Inc., Fort Myers, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1505-2021 Class II | ScooterSeat baseplate pin has broken in the field. | 04/01/2021Open, Classified |