Z-0503-2015 Class II Terminated
FDA device recall Z-0503-2015 was initiated by Snug Seat Inc on August 26, 2013 and is designated Class II. Reason for recall: The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge. The recall status is terminated (terminated December 4, 2017). Affected quantity: 726 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- August 26, 2013
- Termination Date
- December 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 726 units
Product Description
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
Reason for Recall
The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
Distribution Pattern
Worldwide Distribution - U.S. Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA & WV; International: Australia, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK
Code Information
GMDN code; 31119