Arterial Blood Sampling Kit
Anesthesiology · 21 CFR 868.1100
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
433 adverse event reports on file
- DELTRANMar 5, 2026MalfunctionUtah Medical Products, Inc.24519657
- ATELLICA VTR SYRINGESDec 18, 2025MalfunctionWestmed Llc2028807-2025-00031
- PORTEX® LINE DRAW PLUSJul 16, 2025MalfunctionIcu Medical, Inc.22519537
- ATELLICA VTR SYRINGESJul 3, 2025MalfunctionWestmed Llc2028807-2025-00016
- MEDEX TRANSTAR BLOOD SAMPLE KIDS KITJun 20, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.1526863-2025-00070
- MEDEX TRANSTAR BLOOD SAMPLE KIDS KITJun 20, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.1526863-2025-00071
- MEDEX TRANSTAR BLOOD SAMPLE KIDS KITMar 11, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.1526863-2025-00014
- MEDEX TRANSTAR BLOOD SAMPLE KIDS KITMar 11, 2025MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.1526863-2025-00015
- PRO-VENT ARTERIAL BLOOD SAMPLING KIT ABG KITMar 10, 2025MalfunctionSmiths Medical Asd, Inc.MW5167446
- ATELLICA VTR SYRINGESMar 7, 2025MalfunctionWestmed Llc2028807-2025-00003
Event type breakdown
Recalls
23 recall events for this product code
- Medline Industries, LPOpen, ClassifiedJun 29, 2026
Medline Convenience Kits:
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Z-2533-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedApr 30, 2026
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Z-2039-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 3, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2292-2023 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedJul 20, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2193-2023 · View FDA record ↗ - SunMed Holdings, LLCTerminatedSep 23, 2022
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH,
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
Z-1779-2022 · View FDA record ↗ - Vyaire MedicalTerminatedAug 28, 2017
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION
Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
Z-3080-2017 · View FDA record ↗ - Westmed IncTerminatedOct 20, 2012
Pulset Arterial Blood Gas (ABG) sampling kit.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Z-0096-2013 · View FDA record ↗ - Westmed IncTerminatedOct 20, 2012
Pulset Arterial Blood Gas (ABG) sampling kit.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Z-0097-2013 · View FDA record ↗ - Westmed IncTerminatedOct 20, 2012
Pulset Arterial Blood Gas (ABG) sampling kit.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Z-0098-2013 · View FDA record ↗ - Westmed IncTerminatedOct 20, 2012
Pulset Arterial Blood Gas (ABG) sampling kit.
Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.
Z-0099-2013 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Caribbean Custom Mold Inc
Santo Domingo, DO
Midwest Sterilization Corp.
JACKSON, MO, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Customed, Inc.
Fajardo, PR, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
Icu Medical Nederland B.v.
Wijchen Gelderland, NL
Utah Medical Products, Inc.
Midvale, UT, US
Cardinal Health 200, Llc
El Paso, TX, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Isomedix Operations Inc.
Northborough, MA, US
Sterigenics Us Llc
West Memphis, AR, US
Medline Industries, Lp - Laredo
LAREDO, TX, US
Icu Medical Czech Republic A. S.
Hranice Olomoucky Kraj, CZ
Utah Medical Products, Ltd.
ATHLONE CO. Leinster, IE
Vygon Usa
Lansdale, PA, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Vygon Mfg
DOVER, NH, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Hantech Medical Device Co., Ltd.
Cixi Zhejiang, CN
Isomedix Operations Inc
El Paso, TX, US
510(k) clearances
58 clearances for this product code
- Smiths Medical Asd, Inc.Aug 1, 2007
K071269 · HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
- Smiths Medical Asd, Inc.Mar 15, 2007
K070340 · SECURE ARTERIAL BLOOD SAMPLING SYSTEM
- Utah Medical Products, Inc.Mar 17, 1997
K955663 · ABC IN-LINE BLOOD SAMPLING KIT
- Devon Industries, Inc.Nov 20, 1995
K954015 · ABG POINT LOK NEEDLE PROTECTION DEVICE
- R-Group Intl.Sep 25, 1995
K954035 · ACTI-FLEX ARTERIAL EXTENSION SET
- Hammer-Plane, Inc.Aug 11, 1995
K950098 · NEEDLE SAFETY COVER
- Sherwood Medical Co.Mar 16, 1995
K945719 · ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
- Martell Medical Products, Inc.Dec 5, 1994
K944941 · PISTON SYRINGE