Recall Z-1683-2020 ยท ILS Adaptor, Hygiene
James Leckey Design Ltd
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.
| Date | Feb 18, 2020 |
| Status | Open, Classified |
| Reason | The firm received reports of a number of broken latches on the floorsitter. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.