• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Firefly

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Firefly see related information
Date Initiated by Firm February 18, 2020
Create Date April 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-1683-2020
Recall Event ID 85086
Product Classification Adaptor, hygiene - Product Code ILS
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.
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.
Recalling Firm/
Manufacturer
James Leckey Design Ltd
19C Ballinderry Road
Lisburn United Kingdom
For Additional Information Contact Ciaran McKinley
44-2892-6007500
Manufacturer Reason
for Recall
The firm received reports of a number of broken latches on the floorsitter.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-