Z-0467-2022 Class III Terminated
FDA device recall Z-0467-2022 was initiated by Ki Mobility Llc on November 19, 2021 and is designated Class III. Reason for recall: The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. The recall status is terminated (terminated October 31, 2022). Affected quantity: 33 units shipped with affected manuals.
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- November 19, 2021
- Termination Date
- October 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units shipped with affected manuals
Product Description
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.
Reason for Recall
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Distribution Pattern
Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.
Code Information
Model No.: TYK; Serial No: TYK0000500, TYK0000501, TYK0000502, TYK0000503, TYK0000504, TYK0000506, TYK0000505, TYK0000507, TYK0000508, TYK0000509, TYK0000510, TYK0000512, TYK0000511, TYK0000513, TYK0000517, TYK0000520, TYK0000518, TYK0000514, TYK0000515, TYK0000519, TYK0000516, TYK0000521, TYK0000522, TYK0000525, TYK0000524, TYK0000526, TYK0000527, TYK0000528, TYK0000530, TYK0000529, TYK0000531, TYK0000532, TYK0000534; UDI: (01)00850013379231(11)2021-04-05(21)TYK0000500, (01)00850013379231(11)2021-04-12(21)TYK0000501, (01)00850013379231(11)2021-04-13(21)TYK0000502, (01)00850013379231(11)2021-04-19(21)TYK0000503, (01)00850013379231(11)2021-04-29(21)TYK0000504, (01)00850013379231(11)2021-06-11(21)TYK0000505, (01)00850013379231(11)2021-06-11(21)TYK0000507, (01)00850013379231(11)2021-06-11(21)TYK0000508, (01)00850013379231(11)2021-07-08(21)TYK0000509,(01)00850013379231(11)2021-07-08(21)TYK0000510, (01)00850013379231(11)2021-06-11(21)TYK0000512, (01)00850013379231(11)2021-07-14(21)TYK0000511, (01)00850013379231(11)2021-08-06(21)TYK0000513, (01)00850013379231(11)2021-08-06(21)TYK0000517, (01)00850013379231(11)2021-08-06(21)TYK0000520, (01)00850013379231(11)2021-08-06(21)TYK0000518, (01)00850013379231(11)2021-08-06(21)TYK0000514, (01)00850013379231(11)2021-08-06(21)TYK0000515, (01)00850013379231(11)2021-08-06(21)TYK0000519, (01)00850013379231(11)2021-08-06(21)TYK0000516, (01)00850013379231(11)2021-08-16(21)TYK0000521, (01)00850013379231(11)2021-09-02(21)TYK0000522, (01)00850013379231(11)2021-09-20(21)TYK0000525, (01)00850013379231(11)2021-09-20(21)TYK0000524, (01)00850013379231(11)2021-10-04(21)TYK0000526, (01)00850013379231(11)2021-10-04(21)TYK0000527, (01)00850013379231(11)2021-10-12(21)TYK0000528, (01)00850013379231(11)2021-10-29(21)TYK0000530, (01)00850013379231(11)2021-10-29(21)TYK0000529, (01)00850013379231(11)2021-11-16(21)TYK0000531, (01)00850013379231(11)2021-11-17(21)TYK0000532, (01)00850013379231(11)2021-11-17(21)TYK0000534.