Recall Z-1019-2015— Sunrise Medical (US) LLC

Name: FDA recall Z-1019-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2014-12-19, terminated 2015-03-10. It names one FDA 510(k) clearance: K973673. Product: Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.. Reason: There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs..

Recalling firm: Sunrise Medical (US) LLC
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2015-03-10
Firm location: Fresno, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K973673 — QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIESSunrise Medical, Inc.·cleared 1997-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.

Reason for recall

There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

Data sourced from openFDA. This site is unofficial and independent of the FDA.