Recall Z-0503-2015

Snug Seat Inc · initiated August 26, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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.

Codes / lots: GMDN code; 31119

Reason for recall

The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.

FDA-determined cause: Nonconforming Material/Component

Action taken

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.

Details

Recall number
Z-0503-2015
Initiated
August 26, 2013
Posted by FDA
December 16, 2014
Terminated
December 4, 2017
Product code
IOR – Wheelchair, Mechanical
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, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK
Recalling firm
Snug Seat Inc, Matthews, NC

Official FDA recall record