Ki Mobility Little Wave Tyke Manual Contains Incorrect Instructions
The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a Class III FDA recall involving only a documentation error, not a physical device defect. No injuries or incidents have been reported. Per the rubric, Class III recalls are typically scored as Low (1) or Moderate (2), with this being purely instructional.
Plain-English summary
The Ki Mobility Little Wave Tyke is a manually operated mobility device designed for children weighing up to 95 pounds. It is intended for assisted mobility and transport while seated.
The manufacturer has recalled instructions for use (IFU) that accompanied 33 units of this device. The IFU contained instructions appropriate for a mechanical wheelchair rather than for the caster-based design of the Little Wave Tyke.
The affected devices were distributed to customers in Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, South Carolina, and Tennessee. The specific serial numbers affected are documented in FDA records.
Consumers with affected units should contact the manufacturer for corrected instructions for use.
The recalled product
- Product
- 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 per
- Manufacturer
- Ki Mobility Llc
- Category
- Medical Device — Mobility Aid
- Hazard
- instruction-error
- documentation-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No.: TYK
- Serial No: TYK0000500
- TYK0000501
- TYK0000502
- TYK0000503
- TYK0000504
- TYK0000506
- TYK0000505
- TYK0000507
- TYK0000508
- TYK0000509
- TYK0000510
- TYK0000512
- TYK0000511
- TYK0000513
- TYK0000517
- TYK0000520
- TYK0000518
- TYK0000514
- TYK0000515
Distribution
Distributed in 8 states:
- IL
- IN
- KY
- MI
- MO
- NC
- SC
- TN
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