Home / Recalls / Epimed International / Z-0089-2018

Z-0089-2018 Class II Terminated

Recalled by Epimed International — Farmers Branch, TX

Recall Details

Product Type
Devices
Report Date
November 15, 2017
Initiation Date
July 24, 2017
Termination Date
July 6, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
263 units

Product Description

TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

Reason for Recall

Potential for partially incomplete seal of product, impacting sterility.

Distribution Pattern

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

Code Information

Lot No. 12358202; Ref No. 125-2035T.

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-2313-2021 Class II — NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile (December 28, 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)