Z-1267-2024 Class I Ongoing
FDA device recall Z-1267-2024 was initiated by ARROW INTERNATIONAL Inc. on Feb 12, 2024 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 1,160,470 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2024
- Initiation Date
- Feb 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1267-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026