Recall Z-1020-2015
Sunrise Medical (US) LLC · initiated December 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Codes / lots: Serial numbers: R4-025066, R4-025051, R4-025010, R4-024771, R4-024738, R4-024649.
Reason for recall
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
FDA-determined cause: Device Design
Action taken
Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.
Details
- Recall number
- Z-1020-2015
- Initiated
- December 19, 2014
- Posted by FDA
- January 27, 2015
- Terminated
- March 10, 2015
- Product code
- IOR – Wheelchair, Mechanical
- Quantity
- 6
- Distribution
- Nationwide Distribution in the states of CO and ME.
- Recalling firm
- Sunrise Medical (US) LLC, Fresno, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1019-2015 Class II | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on… | 12/19/2014Terminated |