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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

ARROW INTERNATIONAL Inc.: QuickFlash Radial Artery Catheterization Kits Recalled for Defective Guidewire

Agency Publication Date: March 21, 2024
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Summary

Arrow International is recalling approximately 1,160,470 QuickFlash Radial Artery Catheterization kits because a component in the guidewire handle or chamber may be defective. Users have reported resistance when trying to use the guidewire, which can lead to multiple arterial punctures as medical professionals attempt to successfully place the device. This issue can cause serious medical complications during surgical procedures including vessel injury or spasms.

Risk

The defective guidewire handle can resist movement, forcing multiple attempts at arterial puncture. This repeated trauma to the artery can cause arterial vasospasm (sudden narrowing of the artery) and direct injury to the blood vessel.

What You Should Do

  1. Identify if you have the affected QuickFlash Radial Artery Catheterization kits by checking the part numbers on the packaging: AK-04220, ASK-04220-FMH1, ASK-04220-HHC, ASK-04220-KSP, ASK-04220-PSU, ASK-04220-UCL1, ASK-04500-AH, ASK-04500-HF-S, NA-04220-S1A, NA-04220-X1A, RA-04220, or RA-04220-W.
  2. Verify the specific lot numbers and UDI/DI identifiers listed in the recall notice, such as lot 13F22E0436 (UDI 20801902190943) or 14F23B0041 (UDI 20801902180678), before use in any medical procedure.
  3. If you are a healthcare provider, immediately stop using the affected lots and quarantine the products to prevent accidental use.
  4. Contact your healthcare provider or Arrow International/Teleflex for further instructions regarding the return or replacement of these devices.
  5. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider notification and potential replacement.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ARROW QuickFlash Radial Artery Catherization Kit (AK-04220)
Model / REF:
AK-04220
Lot Numbers:
13F22E0436
13F22H0360
33F23E0375
33F23K0032
33F23J0443
33F23L0862
13F22L0105
13F23A0651
33F23C0100
33F23F0347
33F23E0501
33F23G0141
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04220-FMH1)
Model / REF:
ASK-04220-FMH1
Lot Numbers:
33F23B0525
33F23H0100
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04220-HHC)
Model / REF:
ASK-04220-HHC
Lot Numbers:
33F23F0067
33F23K0278
33F23G0478
33F23H0101
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04220-KSP)
Model / REF:
ASK-04220-KSP
Lot Numbers:
33F23E0709
33F23H0102
33F23H0918
33F23J0607
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04220-PSU)
Model / REF:
ASK-04220-PSU
Lot Numbers:
33F23F0331
33F23G0663
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04220-UCL1)
Model / REF:
ASK-04220-UCL1
Lot Numbers:
33F23F0801
33F23C0726
33F23H0320
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04500-AH)
Model / REF:
ASK-04500-AH
Lot Numbers:
33F23E0731
33F23H0103
33F23H0395
Product: ARROW QuickFlash Radial Artery Catherization Kit (ASK-04500-HF-S)
Model / REF:
ASK-04500-HF-S
Lot Numbers:
33F23F0202
33F23H0104
33F23H0396
Product: ARROW QuickFlash Radial Artery Catherization Kit (NA-04220-S1A)
Model / REF:
NA-04220-S1A
Lot Numbers:
33F23J0671
Product: ARROW QuickFlash Radial Artery Catherization Kit (NA-04220-X1A)
Model / REF:
NA-04220-X1A
Lot Numbers:
33F23F0704
Product: ARROW QuickFlash Radial Artery Catherization Kit (RA-04220)
Model / REF:
RA-04220
Lot Numbers (113):
14F23B0041
14F21L0189
14F21L0190
14F21L0250
14F21L0251
14F21L0252
14F21L0253
14F21M0130
14F21M0131
14F21M0205
14F21M0206
14F22A0044
14F22A0123
14F22A0124
14F22A0143
14F22A0144
14F22B0163
14F22B0164
14F22B0175
14F22C0017
14F22C0018
14F22C0019
14F22C0020
14F22C0021
14F22C0022
14F22C0216
14F22C0284
14F22C0346
14F22C0347
14F22D0023
14F22D0024
14F22D0110
14F22D0217
14F22D0291
14S22D0218
14F22E0016
14F22E0173
14F22E0215
14F22F0003
14F22F0062
14F22F0208
14F22F0209
14F22F0210
14F22F0212
14F22F0335
14F22F0336
14F22G0297
14F22G0298
14F22G0325
14F22G0326
Product: ARROW QuickFlash Radial Artery Catherization Kit (RA-04220-W)
Model / REF:
RA-04220-W
Lot Numbers:
13F22E0142
13F22H0417
13F22J0586
13F22M0442
13F23C0015
13F23J0017
13F22F0124
13F23B0363
13F23H0010
13F23J0013
13F23K0001

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94033
Status: Active
Manufacturer: ARROW INTERNATIONAL Inc.
Sold By: hospitals; medical distributors
Manufactured In: United States
Units Affected: 1,160,470 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.