Anesthesia Conduction Kit
Anesthesiology · 21 CFR 868.5140
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
5,152 adverse event reports on file
- Portex Epidural Continuous TraysJul 27, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07691
- EPISPIN NRFITJul 15, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00017
- EPIDURAL TRAYJul 9, 2026MalfunctionAvanos Medical Inc.2026095-2026-00062
- ON-Q PAIN RELIEF SYSTEM T-BLOC ECHOGENIC NEEDLE/CATHETER SETJul 8, 2026MalfunctionAvanos Medical Inc.2026095-2026-00056
- PORTEX EPIDURAL CONTINUOUS TRAYSJul 7, 2026MalfunctionIcu Medical, Inc.1217052-2026-00038
- PORTEX EPIDURAL CONTINUOUS TRAYSJul 3, 2026MalfunctionIcu Medical, Inc.3012307300-2026-06867
- ARROW EPIDURAL CATHETERIZATION KITJun 30, 2026MalfunctionArrow International Llc9680794-2026-00497
- ARROW EPIDURAL CATHETERIZATION KITJun 30, 2026MalfunctionArrow International Llc9680794-2026-00498
- ARTERIAL LINEJun 29, 2026MalfunctionTeleflex Medical Llc25650241
- ON-Q PAIN RELIEF SYSTEM T-BLOC ECHOGENIC NEEDLE/CATHETER SETJun 26, 2026MalfunctionAvanos Medical Inc.2026095-2026-00052
Event type breakdown
Recalls
220 recall events for this product code
- ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2364-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 40
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2248-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 4
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2249-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 40
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2250-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 4
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2251-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers:
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2252-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2253-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 4
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2254-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers:
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2255-2026 · View FDA record ↗ - Becton Dickinson & CompanyOpen, ClassifiedMay 29, 2026
BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 4
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2256-2026 · View FDA record ↗
Registered firms
353 firms currently registered for this product code
Teleflex Medical Llc
Morrisville, NC, US
Hmc Premedical S.p.a.
MIRANDOLA Modena, IT
Arrow International Llc (subsidiary Of Teleflex Incorporated)
Morrisville, NC, US
Sterigenics U.s., Llc
Charlotte, NC, US
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Sterigenics U.s., Llc
Queensbury, NY, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Sterigenics U.s., Llc
Ontario, CA, US
Ych Distripark Sdn Bhd
Prai Pulau Pinang, MY
B. Braun Medical Inc.
Allentown, PA, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Arrow International Cr, A.s.
Hradec Kralove, CZ
Vascular Solutions Llc
Maple Grove, MN, US
Rhenus Se & Co. Kg
Holzwickede North Rhine-Westphalia, DE
Icu Medical Czech Republic A. S.
Hranice Olomoucky Kraj, CZ
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
510(k) clearances
155 clearances for this product code
- Arrow International, LLCFeb 13, 2023
K222341 · Arrow 0.2 Micron Flat Filter, GVS
- Becton, Dickinson and CompanyMay 19, 2022
K210983 · BD Epilor Syringe
- Jiangsu Caina Medical Co.,LtdFeb 12, 2021
K201356 · Plastic LOR Syringe
- PAJUNK GmbH MedizintechnologieDec 29, 2020
K202699 · E-Cath STIM acc. Tsui
- PAJUNK GmbH MedizintechnologieMay 16, 2019
K190345 · VPC
- Teleflexmedical, Inc.Oct 4, 2016
K161075 · Arrow Epidural Catheter Kit
- Teleflex, Inc.Jun 21, 2016
K153652 · ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
- Teleflexmedical, Inc.Jun 26, 2015
K143581 · Arrow Epidural Catheter Kit