Home / Recalls / Epimed International / Z-2313-2021

Z-2313-2021 Class II

Recalled by Epimed International — Farmers Branch, TX

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
December 28, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

Product Description

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Reason for Recall

Potential for stylet to protrude from the distal end of the catheter

Distribution Pattern

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

Code Information

Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)

Other recalls by Epimed International

  • Z-1276-2021 Class II — Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Ca (February 1, 2021)
  • Z-1849-2020 Class II — R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; RE (February 21, 2020)
  • Z-1850-2020 Class II — R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; RE (February 21, 2020)
  • Z-2069-2019 Class II — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, (June 18, 2019)
  • Z-2068-2019 Class II — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, (June 18, 2019)
  • Z-2312-2021 Class II — NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile (December 28, 2017)
  • Z-0089-2018 Class II — TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, (July 24, 2017)
  • Z-0088-2018 Class II — COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Cont (July 24, 2017)
  • Z-0087-2018 Class II — RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic (July 24, 2017)
  • Z-0086-2017 Class II — 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidu (April 22, 2016)