Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
FDA device recall Z-1019-2015 · posted 2015-01-27 · Terminated
Recall details
- Recalling firm
- Sunrise Medical (US) LLC
- Reason for recall
- There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 3
- Distribution
- Nationwide Distribution in the states of CO and ME.
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-27
- Date terminated
- 2015-03-10
- Location
- Fresno, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES (K973673) | Sunrise Medical, Inc. | 1997-11-20 |