Reported Jun 24, 2026 · Ongoing

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT:…

Arrow International, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ARROW INTERNATIONAL, LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437

Is this the product you have?

53 of 53 products

Products covered by this recall
#Product as published
1Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC
2RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW
3ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5
4CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH
5CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC
6ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL
7RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC
8ARTERIAL CATHETERIZATION KIT/ASK-01218-HM
9SAC KIT: 20 GA X 12CM/ASK-01220-HMH
10ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM
11ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH
12ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU
13RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL
14ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH
15ARTERIAL CATHETERIZATION KIT/ASK-01618-PH
16ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU
17ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF
18ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS
19ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST
20RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH
Lot codes and dates

54 of 54 products

Products covered by this recall
#BarcodesProduct as published
11080190212155110801902193275AK-04020-SPC/10801902121551, 10801902193275/33F23M0171, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054
21080190214298310801902193275ASK-04020-MW/10801902142983, 10801902193275/33F23M0188, 33F24B0447, 33F24C0744, 33F24E0725, 33F24G0231, 33F24G0669, 33F24H0344, 33F24L0005, 33F24L0024, 33F25A0062, 33F25B0064, 33F25D0290, 33F25D0729, 33F25E0428, 33F25H0328, 33F26B0089, 33F26B0263
310801902193275ASK-04510-MM5/10801902193275/33F24K0360, 33F25A0237, 33F25B0546
41080190213878810801902193275ASK-00520-JH/10801902138788, 10801902193275/33F24D0201, 33F24F0686, 33F24J0128, 33F24K0373, 33F25A0204, 33F25B0541, 33F25D0324, 33F25D0645, 33F25H0429, 33F25H0507, 33F25J0195, 33F26A1380, 33F26B0159, 33F26C0192
51080190213983910801902193275ASK-00520-UHC/10801902139839, 10801902193275/33F23L0771, 33F24A0775, 33F24B0219, 33F24C0125, 33F24D0093, 33F24E0383, 33F24G0386, 33F24J0284, 33F24K0149, 33F24L0712, 33F25A0495, 33F25C0125, 33F25C0826, 33F25E0099, 33F25H0047, 33F25J0851, 33F25L0392, 33F26B0540
61080190219327510801902193916ASK-00820-CL/10801902193275, 10801902193916/33F24G0275, 33F24J0285, 33F24K0152, 33F24L0590, 33F25A0497, 33F25C0797, 33F25E0102, 33F25H0050, 33F25J0853, 33F25L0385, 33F26B0536
710801902193275ASK-00820-WC/10801902193275/33F24G0150, 33F24G0227, 33F24G0691, 33F24H0253, 33F24K0624, 33F25B0091, 33F25B0334, 33F25J0574, 33F26B0113
810801902193275ASK-01218-HM/10801902193275/33F24G0276, 33F24K0551, 33F24L0215, 33F25A0296, 33F25B0543, 33F25E0450, 33F25F0364, 33F25G0163, 33F25G0208, 33F25H0499, 33F25J0100, 33F25J0139
910801902193275ASK-01220-HMH/10801902193275/33F25B0245, 33F25B0544, 33F25C0698, 33F25D0388
1010801902193275ASK-01220-NWM/10801902193275/33F24H0181, 33F24J0154, 33F24K0497, 33F25F0157, 33F25H0658
1110801902193275ASK-01220-UH/10801902193275/33F24G0391, 33F24J0286, 33F24J0541, 33F24K0154, 33F24L0663, 33F25C0126, 33F25E0104, 33F25E0955, 33F25H0052, 33F25J0494, 33F25J0855, 33F25L0459, 33F25M0952
121080190220590910801902193275ASK-01618-AU/10801902205909, 10801902193275/33F24F0213, 33F24K0673, 33F25C0653, 33F25E1171, 33F25L0062, 33F26A0233
131080190219593410801902193275ASK-01618-CL/10801902195934, 10801902193275/33F24E0648, 33F24K0355, 33F25A0224,33F25B0493, 33F25D0327, 33F25E0588, 33F25F0158, 33F25J0140, 33F25M0112, 33F26C0366
141080190213880110801902193275ASK-01618-JH/10801902138801, 10801902193275/33F24D0584, 33F24K0490, 33F24L0844, 33F25B0494, 33F25D0530, 33F25H0834, 33F25K0264, 33F25K0357, 33S25D0530
1510801902193275ASK-01618-PH/10801902193275/33F24K0749, 33F24L0837, 33F25C0251, 33F25E0019, 33F25G0220
161080190220230410801902193275ASK-01618-RU/10801902202304, 10801902193275/33F24B0869, 33F24D1027, 33F25A0102, 33F25C0713, 33F25J0792, 33F25M0618
1710801902193275ASK-04018-HF/10801902193275/33F24H0156, 33F24L0397, 33F25D0391, 33F25G0401, 33F25K0069, 33F25M0142
1810801902193275ASK-04018-NS/10801902193275/33F25E1176, 33F25G0103
191080190211763910801902193275ASK-04018-ST/10801902117639, 10801902193275/33F24A0112, 33F24A0826, 33F24B0237, 33F24C0140, 33F24E0402, 33F24E0403, 33F24G0281, 33F24K0163, 33F25A0504, 33F25C0780, 33F25E0115, 33F25G0104, 33F25J0498, 33F25M0917, 33F26B1011
201080190211793610801902193275ASK-04120-BGH/10801902117936, 10801902193275/33F24D0518, 33F24G0262, 33F24J0474, 33F25A0150, 33F25C0740, 33F25E1207, 33F25H0096, 33F25K0331
Amount recalled
491,489

This recall covers 35 products

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

Where it was sold

Why it was recalled

Stop using this product now

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Using this product could cause serious injury, illness or death — stop using it now.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

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