Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.
FDA Recall Z-0453-2014 · Posted 2013-12-05
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Recalling FirmSunrise Medical (US) LLC
Recall StatusTerminated
Product CodeIOR
Date Initiated2013-11-11
Date Terminated2014-03-18
Product Quantity316 units in US, 29 units international
Reason for Recall
There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
Firm Action
Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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