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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94033

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 12, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
ARROW INTERNATIONAL Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1267-2024
Recall number
Z-1267-2024
Initiated
February 12, 2024
Classification
Class I
Status
Ongoing
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
1,160,470 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

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

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.