Home / Recalls / Winco Mfg., LLC / Z-2403-2015

Z-2403-2015 Class II Terminated

Recalled by Winco Mfg., LLC — Ocala, FL

FDA device recall Z-2403-2015 was initiated by Winco Mfg., LLC on April 2, 2015 and is designated Class II. Reason for recall: Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. The recall status is terminated (terminated December 14, 2016). Affected quantity: 1 chairs.

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
April 2, 2015
Termination Date
December 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 chairs

Product Description

Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)

Reason for Recall

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Distribution Pattern

Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

Code Information

Model Number: 6980, Serial Numbers: 698101503

Other recalls by Winco Mfg., LLC

  • Z-0064-2017 Class II — TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair (June 29, 2016)
  • Z-0065-2017 Class II — TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use (June 29, 2016)
  • Z-0066-2017 Class II — TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended u (June 29, 2016)
  • Z-2401-2015 Class II — Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology (April 2, 2015)
  • Z-2400-2015 Class II — Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncolog (April 2, 2015)
  • Z-2393-2015 Class II — Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Rec (April 2, 2015)
  • Z-2391-2015 Class II — Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (April 2, 2015)
  • Z-2396-2015 Class II — Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Ho (April 2, 2015)
  • Z-2398-2015 Class II — Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Re (April 2, 2015)
  • Z-2399-2015 Class II — Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis (April 2, 2015)

FDA data resources