Recall Z-0453-2014— Sunrise Medical (US) LLC
Class II · Terminated
Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2013-11-11, terminated 2014-03-18. It names one FDA 510(k) clearance: K123975. Product: 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.. Reason: 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..
- Recalling firm
- Sunrise Medical (US) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-11
- Terminated
- 2014-03-18
- Firm location
- Fresno, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.