Farmers Branch, TX, United States
Epimed International recalls
4 recalls recorded since 2018, most recently on 1 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 February 2021
- Terminated
- 17 October 2022
- Reason
- Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1276-2021
- Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Terminated Class II Medical devices
- Recall started
- 21 February 2020
- Terminated
- 28 January 2021
- Reason
- Incorrect expiration date on introduction cannula packaging.
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AL, CA, FL, GA, IL, MD,MI, MS, NJ, NY, OK, TN, TX, WA and WY and the countries of Australia, Chile, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1849-2020, Z-1850-2020
- R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesio
- R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion
Terminated Class II Medical devices
- Recall started
- 18 June 2019
- Reason
- Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
- Distribution
- Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2069-2019, Z-2068-2019
- Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
- Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
Completed Class II Medical devices
- Recall started
- 28 December 2017
- Reason
- Potential for stylet to protrude from the distal end of the catheter
- Distribution
- Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2313-2021, Z-2312-2021
- NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.