Recall Z-1505-2021 ยท INI Vehicle, Motorized 3-Wheeled
Merits Holdings Co. dba Merits Health Products, Inc.
Scooter
| Date | Apr 1, 2021 |
| Status | Open, Classified |
| Reason | Seat baseplate pin has broken in the field. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 189 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011707 | TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 Merits Medical Industries Co., Ltd., Aug 3, 2001 |
| K011751 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 Merits Health Products., Inc., Aug 6, 2001 |
| K011753 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 Merits Health Products., Inc., Aug 3, 2001 |
| K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 Merits Health Products Co., Ltd., May 1, 2015 |
| K952042 | TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER Merits Health Products Co., Ltd., Mar 4, 1996 |