Recall Z-0503-2015 ยท IOR Wheelchair, Mechanical
Snug Seat Inc
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.
| Date | Dec 16, 2014 (initiated Aug 26, 2013) |
| Status | Terminated |
| Reason | The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Field Safety Notice letter dated August 26, 2013 and September 17, 2013 was sent to customers. The letter identified the affected product, problem and actions to be taken. New replacement bolts were provided to customers. |
| Quantity | 726 units |
| Distribution | 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, Ger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934560 | WIZARD PEDIATRIC WHEELCHAIR Snug Seat, Inc., Jan 7, 1994 |