ARROW QuickFlash Radial Artery Catherization — Class I medical device recall Z-1267-2024
Ongoing recall by ARROW INTERNATIONAL Inc., reported 2024-03-27, distributed nationwide. Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicati
| Recall number | Z-1267-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2024-02-12 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 1,160,470 devices |
| UPC / GTIN / UDI-DI | 20801902111665, 20801902114048, 20801902136606, 20801902139416, 20801902156406, 20801902159124, 20801902180678, 20801902190851, 20801902190943, 30801902121616, 30801902193309, 30801902193316, 30801902202988, 30801902210631, 40801902118002, 40801902121446 |
| Lot numbers | 13F22E0142, 13F22E0436, 13F22F0124, 13F22H0360, 13F22H0417, 13F22J0586, 13F22L0105, 13F22M0442, 13F23A0651, 13F23B0363, 13F23C0015, 13F23H0010, 13F23J0013, 13F23J0017, 13F23K0001, 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 and 119 more |
| Model numbers | AK-04220, ASK-04220-FMH1, ASK-04220-HHC, ASK-04220-KSP, ASK-04220-PSU, ASK-04220-UCL1, ASK-04500-AH, ASK-04500-HF-S, NA-04220-S1A, NA-04220-X1A, RA-04220, RA-04220-W |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1267-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.