Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0503-2015Class II

Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities

R82 Inc. / initiated 2013-08-26 / Terminated / root cause: manufacturing process

Snug Seat Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0503-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
R82 Inc.
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.
Product code
IOR Wheelchair, Mechanical
Reason for recall
The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
Root cause tag
manufacturing process
FDA 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 in commerce
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
Product codes and lots
GMDN code; 31119

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0503-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0503-2015Class IITerminatedVoluntary: Firm initiated