Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bat...
FDA Device Recall #Z-1683-2020 — Class II — February 18, 2020
Recall Summary
| Recall Number | Z-1683-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | James Leckey Design Ltd |
| Location | Lisburn, N/A |
| Product Type | Devices |
| Quantity | 1,241 units |
Product Description
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.
Reason for Recall
The firm received reports of a number of broken latches on the floorsitter.
Distribution Pattern
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.
Lot / Code Information
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.
Other Recalls from James Leckey Design Ltd
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1687-2021 | Class II | MyWay Walker Chassis - Product Usage: is intend... | Mar 1, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.