# FDA recall Z-1267-2024

> **ARROW INTERNATIONAL Inc.** · Class I · device recall initiated 2024-02-12.

## Product

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

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.

## Key facts

- **Recall number:** Z-1267-2024
- **Recalling firm:** ARROW INTERNATIONAL Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-12
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2024

## Citation

> AI Analytics. FDA recall Z-1267-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1267-2024. Source: US FDA. Licensed CC0.

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