Recall Z-1504-2021— Merits Holdings Co. dba Merits Health Products, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merits Holdings Co. dba Merits Health Products, Inc., initiated 2021-04-01. It names 5 FDA 510(k) clearances: K122357, K012802, K011513 and 2 more. Product: Power Wheelchair. Reason: Seat baseplate pin has broken in the field..
- Recalling firm
- Merits Holdings Co. dba Merits Health Products, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-04-01
- Firm location
- Fort Myers, FL, United States
510(k) clearances named in this recall
5 on FDA's record- K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIR
- K012802 — MP3CF ELECTRIC WHEELCHAIR
- K011513 — MP3U, POWER WHEELCHAIR
- K011687 — MP-3C POWER BASE CHAIR, MODEL MP3C
- K993032 — MODIFICATION TO MP-3 POWER BASE CHAIR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Power Wheelchair
Reason for recall
Seat baseplate pin has broken in the field.
Data sourced from openFDA. This site is unofficial and independent of the FDA.