Catheter, Conduction, Anesthetic
Anesthesiology · 21 CFR 868.5120
Recent MDR events
2,605 adverse event reports on file
- ARROW EPIDURAL CATHETERIZATION SETJul 29, 2026MalfunctionArrow International Llc3006425876-2026-00814
- ARROW EPIDURAL CATHETERIZATION KIT NRFITJul 29, 2026MalfunctionArrow International Llc3006425876-2026-00822
- ARROW EPIDURAL CATHETERIZATION SETJul 29, 2026MalfunctionArrow International Llc3006425876-2026-00857
- 18G LOCKIT PLUS REGIONAL ANAESCATHETER SECUREMENT DEVICEJul 29, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.2025816-2026-00034
- EPIDURAL CATHETERIZATION SETJul 28, 2026MalfunctionArrow International Llc3006425876-2026-00806
- EPIDURAL CATHETERIZATION SETJul 28, 2026MalfunctionArrow International Llc3006425876-2026-00796
- EPIDURAL CATHETERIZATION SETJul 28, 2026MalfunctionArrow International Llc3006425876-2026-00813
- EPIDURAL CATHETERIZATION SETJul 28, 2026MalfunctionArrow International Llc3006425876-2026-00812
- ARROW EPIDURAL CATHETERIZATION SETJul 22, 2026MalfunctionArrow International Llc3006425876-2026-00798
- ARROW EPIDURAL CATHETERIZATION SETJul 22, 2026MalfunctionArrow International Llc3006425876-2026-00797
Event type breakdown
Recalls
119 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-2371-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedApr 22, 2026
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Z-1913-2026 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1172-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1174-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1177-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1178-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1182-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1184-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1185-2020 · View FDA record ↗ - Arrow International IncTerminatedJan 24, 2020
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1193-2020 · View FDA record ↗
Registered firms
139 firms currently registered for this product code
B. Braun Medical Inc.
Allentown, PA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Epimed International, Inc.
JOHNSTOWN, NY, US
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Spinal Elements, Inc.
CARLSBAD, CA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Epimed International, Inc.
Dallas, TX, US
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
B. Braun Medical Inc.
BETHLEHEM, PA, US
Avent S. De R.l. De C.v.
TIJUANA Baja California, MX
Sterigenics U.s., Llc
Corona, CA, US
Isomedix Operations, Inc.
Temecula, CA, US
Avanos Medical, Inc.
Alpharetta, GA, US
Exel Inc.
Southaven, MS, US
510(k) clearances
75 clearances for this product code
- Jmt Co., Ltd.Feb 13, 2025
K241410 · EDEN ControlCath
- B.Braun Medical, Inc.Sep 15, 2023
K231242 · Perifix FX Catheter; Contiplex FX Catheter
- Teleflex MedicalAug 30, 2023
K230603 · Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
- Hk SurgicalSep 9, 2020
K193664 · SubQKath Catheter and Needle Set
- Epimed International, Inc.Apr 27, 2020
K200624 · Percutaneous Introducer
- Cimpax ApsOct 25, 2019
K191470 · C-CAT Anaesthesia Catheter kit
- Medline Industries, Inc.Mar 4, 2019
K181782 · Medline Reinforced Epidural Catheter
- Imedicom Co., Ltd.Aug 24, 2018
K173541 · EPINAUT