Recall Z-1504-2021 ยท ITI Wheelchair, Powered
Merits Holdings Co. dba Merits Health Products, Inc.
Power Wheelchair
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011513 | MP3U, POWER WHEELCHAIR Merits Health Products., Inc., Aug 10, 2001 |
| K011687 | MP-3C POWER BASE CHAIR, MODEL MP3C Merits Health Products., Inc., Aug 3, 2001 |
| K012802 | MP3CF ELECTRIC WHEELCHAIR Merits Health Products., Inc., Sep 18, 2001 |
| K122357 | MERITS MODEL P322FWD POWERED WHEELCHAIR Merits Health Products Co., Ltd., Jan 9, 2013 |
| K993032 | MODIFICATION TO MP-3 POWER BASE CHAIR Merits Health Products., Inc., Nov 5, 1999 |