Recall Z-0467-2022 ยท INM Chair, With Casters
Ki Mobility Llc
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.
| Date | Nov 19, 2021 |
| Status | Terminated |
| Reason | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |
| Root cause | Process design |
| Action | The firm distributed a Medical Device Correction Notice dated 12/07/2021 by first class mail to consignees. The notificaiton identified the reason for recall as the Owner's Manual/Instructions for Use for the Little Wave Tyke contained information intended for a mechanical wheelchair, not a mechanical chair with casters. Customers were instructed to distribute the provided updated Little Wave Tyke Owner's Manual/Instructions for Use (DCN0569.2) to end users, and if available request that customers destroy or dispose of the previous versions of the manual (DCN0569.0 and DCN0569.1). The updated |
| Quantity | 33 units shipped with affected manuals |
| Distribution | Domestic: IL, IN, KY, MI, MO, NC, SC, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.