Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile
FDA device recall Z-0503-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Snug Seat Inc
- Reason for recall
- The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 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
- Date initiated
- 2013-08-26
- Date posted
- 2014-12-16
- Date terminated
- 2017-12-04
- Location
- Matthews, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WIZARD PEDIATRIC WHEELCHAIR (K934560) | Snug Seat, Inc. | 1994-01-07 |