Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1683-2020Class II

Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat -

James Leckey Design Ltd / initiated 2020-02-18 / Open, Classified / root cause: design

James Leckey Design Ltd began a recall of Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo... on . FDA classified it as Class II and gives the reason as "The firm received reports of a number of broken latches on the floorsitter". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1683-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
James Leckey Design Ltd
Product
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
Product code
ILS Adaptor, Hygiene
Reason for recall
The firm received reports of a number of broken latches on the floorsitter.
Root cause tag
design
FDA root cause
Device Design
Action
James Leckey notified customers on 09/23/2019 via "Urgent Field Safety letter". The letter identified the affected product, serial numbers and date of manufacturing. The customers were asked to complete the form and new parts will be sent to all affected customers.
Quantity in commerce
1,241 units
Distribution
US Nationwide distribution in the states of AL, AZ, AR, CA, CT, CO, FL, GA, SC, IA, HI, ID, IL, KS, KY, IN, MD, MA, LA, ME, MN, MI, MO, MT, NC, , NE, NH, ND, RI, TX, TN, VT, UT, WV, WA and WI.
Product codes and lots
LEC/178486 to LEC/206637; LEC/189092 to LEC/204087; Firefly Splashy-All codes beginning 176; Firefly GoTo Seat-All codes beginning 167 and including letter F in code.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1683-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1683-2020Class IIOngoingVoluntary: Firm initiated