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Terminated

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.

FDA Recall Z-0503-2015 · Posted 2014-12-16

Recalling FirmSnug Seat Inc
Recall StatusTerminated
Product CodeIOR
Date Initiated2013-08-26
Date Terminated2017-12-04
Product Quantity726 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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