Arrow Arterial Kits and Trays as follows: — Class II medical device recall Z-3299-2024
Ongoing recall by ARROW INTERNATIONAL Inc., reported 2024-10-02, distributed nationwide. Reports have been received regarding open seals on the packaging.
| Recall number | Z-3299-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2024-07-26 |
| Classified | 2024-09-26 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 14,845 kits |
| UPC / GTIN / UDI-DI | 00801902091215, 10801902117585, 10801902117691, 10801902144765, 10801902155938, 10801902156409, 10801902158854, 10801902200461, 10801902206401, 10801902211429, 10801902214802, 10801902218978, 10801902219630, 20801902117711, 30801902144578 |
| Lot numbers | 33F23J0777, 33F23K0602, 33F23K0881, 33F23K1006, 33F23L0297, 33F23L0323, 33F23L0687, 33F23L0734, 33F23L0738, 33F23L0747, 33F23M0033, 33F23M0157, 33F24A0036, 33F24A0260, 33F24A0314, 33F24A0380, 33F24A0390, 33F24A0617, 33F24A0711, 33F24A0731, 33F24A0743, 33F24A0825, 33F24A0901, 33F24A1033, 33F24A1129, 33F24A1135, 33F24A1676, 33F24B0001, 33F24B0233, 33F24B0235, 33F24B0254, 33F24B0255, 33F24B0788, 33F24C0002, 33F24C0136, 33F24C0157, 33F24C0436, 33F24C0678, 33F24D0964, 33F24D0969 |
| Model numbers | ASK-04001-BW1, ASK-04001-CK, ASK-04001-VAMC1, ASK-04020-BHS, ASK-04020-BID, ASK-04020-HMC, ASK-04020-HOA, ASK-04020-KSD, ASK-04020-LOL, ASK-04020-MHS, ASK-04020-MIB3, ASK-04020-PRH, ASK-04020-UOIL, ASK-04220-KSP, ASK-04500-HFH4 |
Product
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.
Reason for recall
Reports have been received regarding open seals on the packaging.
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-3299-2024. 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.