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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ARROW INTERNATIONAL Inc.: Arrow Arterial Kits and Trays Recalled for Compromised Sterile Packaging

Agency Publication Date: September 26, 2024
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Summary

ARROW INTERNATIONAL Inc. is recalling 14,845 Arrow Arterial Kits and Trays because the seals on the packaging may be open. These kits are used for arterial access and catheterization in medical settings. If the packaging seal is broken, the medical tools inside are no longer sterile, which can lead to serious infections in patients. These kits were distributed to government facilities and nationwide across several states including California, Florida, and New York between late 2023 and early 2024.

Risk

Open packaging seals compromise the sterile barrier of the medical device. Using non-sterile arterial kits can introduce bacteria or other pathogens directly into a patient's bloodstream or arterial system, potentially causing life-threatening infections or sepsis.

What You Should Do

  1. Immediately inspect your inventory for the affected Arrow Arterial Kits and Trays by matching the REF (Reference) numbers and Batch/Lot numbers on the packaging.
  2. Identify affected products: REF ASK-04001-BW1 (Batches 33F23M0157, 33F24C0002, 33F24C0136, 33F23L0297); REF ASK-04001-CK (Batches 33F24A0390, 33F24B0233, 33F24A0260, 33F24A0036, 33F23L0738); and REF ASK-04001-VAMC1 (Batches 33F24A0825, 33F24B0235).
  3. Check for additional affected products: REF ASK-04020-BHS (Batches 33F24C0678, 33F23K0881, 33F24B0788, 33F24A1676, 33F24A0711, 33F23L0687); REF ASK-04020-BID (Batch 33F23J0777); and REF ASK-04020-HMC (Batches 33F24A0743, 33F23L0747, 33F24A1129).
  4. Check for other affected models: REF ASK-04020-HOA (Batch 33F24D0969); REF ASK-04020-KSD (Batch 33F24D0964); REF ASK-04020-LOL (Batches 33F24A1135, 33F24B0254, 33F24A0731, 33F24A0314, 33F23M0033); and REF ASK-04020-MHS (Batches 33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, 33F23L0734).
  5. Check final affected models: REF ASK-04020-MIB3 (Batch 33F24A0901); REF ASK-04020-PRH (Batch 33F23K0602); REF ASK-04020-UOIL (Batch 33F24B0001); REF ASK-04220-KSP (Batch 33F23L0323); and REF ASK-04500-HFH4 (Batches 33F24C0436, 33F24A0617, 33F23K1006).
  6. Stop using all affected kits immediately and quarantine them to prevent accidental use.
  7. Contact your healthcare provider if you believe a compromised kit was used during a medical procedure, or contact ARROW INTERNATIONAL Inc. for further instructions regarding the return or replacement of these products.
  8. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and contact for further instructions

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

Affected Products

Product: Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included)
Model / REF:
ASK-04001-BW1
UPC Codes:
10801902117585
Lot Numbers:
33F23M0157
33F24C0002
33F24C0136
33F23L0297
Product: Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included)
Model / REF:
ASK-04001-CK
UPC Codes:
00801902091215
Lot Numbers:
33F24A0390
33F24B0233
33F24A0260
33F24A0036
33F23L0738
Product: Arrow Arterial Access Kit, .025 inch dia. spring-wire guide
Model / REF:
ASK-04001-VAMC1
UPC Codes:
10801902158854
Lot Numbers:
33F24A0825
33F24B0235
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide
Model / REF:
ASK-04020-BHS
UPC Codes:
30801902144578
Lot Numbers:
33F24C0678
33F23K0881
33F24B0788
33F24A1676
33F24A0711
33F23L0687
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide
Model / REF:
ASK-04020-BID
UPC Codes:
10801902211429
Lot Numbers:
33F23J0777
Date Ranges: Exp: 2026-03-31
Product: Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide
Model / REF:
ASK-04020-HMC
UPC Codes:
10801902117691
Lot Numbers:
33F24A0743
33F23L0747
33F24A1129
Product: Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide (HOA)
Model / REF:
ASK-04020-HOA
UPC Codes:
10801902214802
Lot Numbers:
33F24D0969
Date Ranges: Exp: 2025-11-24
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide (KSD)
Model / REF:
ASK-04020-KSD
UPC Codes:
10801902219630
Lot Numbers:
33F24D0964
Date Ranges: Exp: 2025-11-30
Product: Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide (LOL)
Model / REF:
ASK-04020-LOL
UPC Codes:
10801902144765
Lot Numbers:
33F24A1135
33F24B0254
33F24A0731
33F24A0314
33F23M0033
Product: Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide
Model / REF:
ASK-04020-MHS
UPC Codes:
20801902117711
Lot Numbers:
33F24A0380
33F24A1033
33F24B0255
33F24C0157
33F23L0734
Date Ranges: Exp: 2026-04-26
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide (MIB3)
Model / REF:
ASK-04020-MIB3
UPC Codes:
10801902206401
Lot Numbers:
33F24A0901
Date Ranges: Exp: 2025-08-31
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide (PRH)
Model / REF:
ASK-04020-PRH
UPC Codes:
10801902155938
Lot Numbers:
33F23K0602
Date Ranges: Exp: 2025-07-31
Product: Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide (UOIL)
Model / REF:
ASK-04020-UOIL
UPC Codes:
10801902218978
Lot Numbers:
33F24B0001
Date Ranges: Exp: 2026-10-31
Product: Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide
Model / REF:
ASK-04220-KSP
UPC Codes:
10801902156409
Lot Numbers:
33F23L0323
Date Ranges: Exp: 2025-05-31
Product: Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide
Model / REF:
ASK-04500-HFH4
UPC Codes:
10801902200461
Lot Numbers:
33F24C0436
33F24A0617
33F23K1006

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95228
Status: Active
Manufacturer: ARROW INTERNATIONAL Inc.
Sold By: Government distribution; Hospitals and medical facilities
Manufactured In: United States
Units Affected: 14,845 kits
Distributed To: California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, North Carolina, New York, Pennsylvania, West Virginia

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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.