Recall Z-0503-2015— Snug Seat Inc

Name: FDA recall Z-0503-2015
Creator: U.S. Food and Drug Administration
Published: 2013-08-26

Class II · Terminated

Class II FDA medical device recall by Snug Seat Inc, initiated 2013-08-26, terminated 2017-12-04. It names one FDA 510(k) clearance: K934560. 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.. Reason: The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge..

Recalling firm: Snug Seat Inc
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Terminated: 2017-12-04
Firm location: Matthews, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K934560 — WIZARD PEDIATRIC WHEELCHAIRSnug Seat, Inc.·cleared 1994-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.