ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-...
FDA Device Recall #Z-1267-2024 — Class I — February 12, 2024
Recall Summary
| Recall Number | Z-1267-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | February 12, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ARROW INTERNATIONAL Inc. |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 1,160,470 devices |
Product Description
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W
Reason for Recall
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
Distribution Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.
Lot / Code Information
a) REF AK-04220, UDI/DI 20801902190943, Lot Numbers: 13F22E0436, 13F22H0360, 33F23E0375, 33F23K0032, 33F23J0443, 33F23L0862; UDI/DI 30801902121616, Lot Numbers: 13F22L0105, 13F23A0651, 33F23C0100, 33F23F0347, 33F23E0501, 33F23G0141; b) REF ASK-04220-FMH1, UDI/DI 20801902111665, Lot Numbers: 33F23B0525, 33F23H0100; c) REF ASK-04220-HHC, UDI/DI 20801902190851, Lot Numbers: 33F23F0067, 33F23K0278, 33F23G0478, 33F23H0101; d) REF ASK-04220-KSP, UDI/DI 20801902156406, Lot Numbers: 33F23E0709, 33F23H0102, 33F23H0918, 33F23J0607; e) REF ASK-04220-PSU, UDI/DI 40801902121446, Lot Numbers: 33F23F0331, 33F23G0663; f) REF ASK-04220-UCL1, UDI/DI 20801902159124, Lot Numbers: 33F23F0801, 33F23C0726, 33F23H0320; g) REF ASK-04500-AH, UDI/DI 20801902114048, Lot Numbers: 33F23E0731, 33F23H0103, 33F23H0395; h) REF ASK-04500-HF-S, UDI/DI 40801902118002, Lot Numbers: 33F23F0202, 33F23H0104, 33F23H0396; i) REF NA-04220-S1A, UDI/DI 20801902139416, Lot Numbers: 33F23J0671; j) REF NA-04220-X1A, UDI/DI 20801902136606, Lot Numbers: 33F23F0704; k) REF RA-04220, UDI/DI 20801902180678, Lot Numbers: 14F23B0041; UDI/DI 30801902193309, Lot Numbers: 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, 14F22H0078, 14F22H0079, 14F22H0250, 14F22J0078, 14F22J0079, 14F22J0080, 14F22J0081, 14F22J0082, 14F22J0083, 14F22J0257; UDI/DI 30801902210631, Lot Numbers: 14F22K0182, 14F22K0183, 14F22K0184, 14F22K0185, 14F22K0223, 14F22M0032, 14F22M0033, 14F22M0034, 14F22M0035, 14F22M0036, 14F22M0132, 14F23B0042, 14F23B0142, 14F23B0143, 14F23B0144, 14F23B0154, 14F23D0203, 14F23D0204, 14F23D0205, 14F23D0206, 14F23D0207, 14F23E0093, 14F23E0094, 14F23E0210, 14F23E0211, 14F23F0036, 14F23F0037, 14F23F0038, 14F23F0252, 14F23F0253, 14F23F0377, 14F23F0378, 14F23F0379, 14F23G0147, 14F23G0148, 14F23G0149, 14F23G0150, 14F23G0151, 14F23G0252, 14F23H0087, 14F23H0088, 14F23H0089, 14F23H0090, 14F23H0163, 14F23H0253, 14F23H0254, 14F23H0255, 14F23J0031, 14F23J0032, 14F23J0137, 14F23J0138, 14F23J0276, 14F23J0277; l) REF RA-04220-W, UDI/DI 30801902193316, Lot Numbers: 13F22E0142, 13F22H0417, 13F22J0586, 13F22M0442, 13F23C0015, 13F23J0017; UDI/DI 30801902202988, Lot Numbers: 13F22F0124, 13F23B0363, 13F23H0010, 13F23J0013, 13F23K0001
Other Recalls from ARROW INTERNATIONAL Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3299-2024 | Class II | Arrow Arterial Kits and Trays as follows: (1... | Jul 26, 2024 |
| Z-1880-2024 | Class I | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter... | Apr 29, 2024 |
| Z-1879-2024 | Class I | Arrow UltraFlex Intra-Aortic Balloon Catheter K... | Apr 29, 2024 |
| Z-1878-2024 | Class I | Arrow FiberOptix Intra-Aortic Balloon Catheter ... | Apr 29, 2024 |
| Z-0003-2024 | Class I | Arrow Pressure Injectable Arrowg+ard Blue Plus¿... | Aug 10, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.