Reported Jun 24, 2026 · Ongoing

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;…

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?

23 of 23 products

Products covered by this recall
#Product as published
1Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F
2HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122
3HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC
4HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC
5HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD
6HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC
7HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD
8HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1
9HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD
10HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F
11HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F
12HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A
13HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A
14HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A
15HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A
16HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC
17HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F
18HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F
19AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU
20AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC
Lot codes and dates

23 of 23 products

Products covered by this recall
#BarcodesProduct as published
11080190219327510801902197129AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A0473, 33F25E0060, 33F25J0473, 33F24A0848
210801902193275AK-22122/10801902193275/33F24H0232, 33F24J0523
310801902193275AK-22142-CDC/10801902193275/33F24J0527, 33F24K0129, 33F24L0649, 33F25C0115, 33F25C0959, 33F25E0940, 33F25J0481, 33F25L0428, 33F24G0364
41080190219327550801902123195AK-25142-CDC/10801902193275, 50801902123195/33F25A0486, 33F25C0892, 33F25E0086, 33F25E0944, 33F25J0485, 33F25J0845, 33F25L0374, 33F26B0521, 33F25A0487
5108019021932751080190213647010801902143690ASK-22142-UMD/10801902193275, 10801902136470, 10801902143690/33F25F0362, 33F25J0094, 33F26A0244, 33F26B0137, 33F24F0041
610801902193275ASK-22142-UNC/10801902193275/33F25G0269, 33F24K0560
71080190219327510801902136500ASK-25142-UMD/10801902193275, 10801902136500/33F25B0239, 33F25E0308, 33F25G0686, 33F25K0425, 33F26A0246, 33F26C0047, 33F24K0696
81080190219327510801902156379ASK-25142-UN1/10801902193275, 10801902156379/33F24L1157, 33F26B0908, 33F25B0420
910801902193275ASK-26142-UMD/10801902193275, 33F26A0408, 33F25B0427
1010801902193275AU-23122-F/10801902193275/33F25C0877, 33F25H0157, 33F24L0038
11108019021932757080190212332810801902210071AU-25122-F/10801902193275, 70801902123328, 10801902210071/33F25G0562, 33R24L0038, 33F24D0400
121080190219327510801902213478CDC-22122-X1A/10801902193275, 10801902213478/33F25E0694, 33F25G0268, 33F24D0693
131080190219327510801902168044CDC-22122-XU1A/10801902193275, 10801902168044/33F25E0652, 33F25H0643, 33F24D0830
1410801902193275CDC-22142-X1A/10801902193275/33F25A0284
1510801902213515CDC-26122-X1A/10801902213515/33F24F1028
161080190219327510801902198492AK-22122-CDC/10801902193275, 10801902198492/33F24K0125, 33F24L0647, 33F25C0114, 33F25E0936, 33F25G0091, 33F24E0355
1710801902193275AK-22122-F/10801902193275/33F24G0360, 33F24J0524, 33F24K0126, 33F25A0482, 33F25E0075, 33F25E0937, 33F25J0839, 33F25L0413, 33F24G0361
1810801902193275AK-22142-F/10801902193275/33F24L0662, 33F25C0117, 33F25C0865, 33F25H0034, 33F25J0841, 33F24K0130
191080190219327510801902222265CDC-22122-CN1AU/10801902193275, 10801902222265/33F26A1388, 33F26B0398, 33F24L0966
2010801902193275CDC-22142-CN1AC/10801902193275/33F26A1550, 33F25J0455
Amount recalled
15,425

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.