Reported Jun 24, 2026 · Ongoing

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM…

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?

24 of 24 products

Products covered by this recall
#Product as published
1Description/REF: ACCESS TRAY/ASK-04001-SUH-S
2ACCESS TRAY/ASK-04001-VM1
3STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS
4STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS
5STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS
6STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK
7FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU
8CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2
9CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC
10CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP
11CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC
12FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K
13FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU
14FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K
15FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU
16CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1
17EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1
18EPIDURAL CATHETERIZATION KIT/MH-05001
19EPIDURAL CATHETERIZATION KIT/WJ-05401
20SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1
Lot codes and dates

24 of 24 products

Products covered by this recall
#BarcodesProduct as published
11080190221021710801902193275ASK-04001-SUH-S/10801902210217, 10801902193275/33F25C0766, 33F25E0112, 33F25G0101, 33F25H0058, 33F25H0725, 33F25J0862, 33F25M0836, 33F25F0160
2108019022102171080190220210610801902193275ASK-04001-VM1/10801902210217, 10801902202106, 10801902193275/33F24L0599, 33F26A0962, 33F24G0280
31080190221021710801902209471AB-19604-KS/10801902210217, 10801902209471/33F24L0608, 33F25G0474, 33F25J0814, 33F25M0887, 33F24D0064
41080190221021710801902209471AB-19608-KS/10801902210217, 10801902209471/33F24E0312, 33F24F0295, 33F24G0316, 33F24K0082, 33F24L0714, 33F25E0027, 33F25E0904, 33F25H0003, 33F25J0815, 33F25L0337, 33F26B0498, 33F24E0314
510801902210217AB-20608-KS/)10801902210217/33F25H0004, 33F25J0816, 33F24D0437
61080190220943310801902210217AB-05060-PK/10801902209433, 10801902210217/33F24D0002, 33F24E0029, 33F24G0315, 33F24J0484, 33F24K0081, 33F25A0451, 33F25C0747, 33F25E0026, 33F25J0646, 33F24E0028
7108019022102171080190220687610801902214291ASK-19609-VCU/10801902210217, 10801902206876, 10801902214291/33F24E0536, 33F24J0630, 33F24L0605, 33F25C0179, 33F25E0220, 33F25H0140, 33F26B1003, 33F24D0628
8108019022100571080190221021710801902210064ASK-19600-CC2/10801902210057, 10801902210217, 10801902210064/33F24D0393, 33F24E0533, 33F24G0494, 33F24K0251, 33F24L0665, 33F25C0177, 33F25E0217, 33F25H0138, 33F24C0230
9108019022102171080190221006410801902202236ASK-19608-CC/10801902210217, 10801902210064, 10801902202236/33F24G0309, 33F24K0252, 33F24L0639, 33F25B0691, 33F25C0178, 33F25C0761, 33F25E0218, 33F25E1022, 33F25H0750, 33F25J0918, 33F26B0230, 33F24D0394
1010801902210217ASK-19608-KP/10801902210217/33F24G0495, 33F24G0086
11108019022102174080190220222010801902202243ASK-19608-SHC/10801902210217, 40801902202220, 10801902202243/33F24G0496, 33F24J0629, 33F24K0253, 33F24L0573, 33F25A0571, 33F25C0733, 33F25E0219, 33F25G0757, 33F25H0139, 33F25J0919, 33F25K0400, 33F25L0480, 33F26B0606, 33F24C0231
121080190221021710801902210125FB-19608-K/10801902210217, 10801902210125/33F24G0533, 33F24J0650, 33F24K0279, 33F24L0568, 33F25C0186, 33F25C0748, 33F25E0257, 33F25G0147, 33F25H0164, 33F25J0623, 33F25L0340, 33F25M0847, 33F24C0258
131080190221021710801902210132FB-19608-KU/10801902210217, 10801902210132/33F24E0026, 33F24E0574, 33F24G0312, 33F24J0328, 33F24L0557, 33F24M0268, 33F25C0187, 33F25C0940, 33F25E0258, 33F25H0165, 33F25J0624, 33F25L0344, 33F25M0851, 33F23G0580
1410801902210132108019022102171080190221013210801902210149FB-19609-K/10801902210132, 10801902210217, 10801902210132, 10801902210149/33F24C0259, 33F24D0407, 33F24E0575, 33F24G0534, 33F24K0281, 33F24L0805, 33F25C0721, 33F25E1042, 33F25J0625, 33F25L0351, 33F25M0856, 33F26B0504, 33F24B0386
1510801902210149108019022102171080190221014910801902193275FB-19609-KU/10801902210149, 10801902210217, 10801902210149, 10801902193275/33F24C0260, 33F24E0576, 33F24E0577, 33F24G0535, 33F24L0763, 33F25A0592, 33F25E0259, 33F25E1043, 33F25H0758, 33F25K0402, 33F25L0471, 33F26B0594, 33F26C0480, 33S24L0763, 33F24L0738
1610801902210217ASK-19608-US1/10801902210217/33F24E0535, 33F24K0254, 33F24L0770, 33F24E0014
171080190221021710801902209617ASK-05001-SLR1/10801902210217, 10801902209617/33F24J0596, 33F24L0560, 33F25A0546, 33F25C0939, 33F25E0177, 33F25E0998, 33F25J0530, 33F24C0194
1810801902210217MH-05001/10801902210217/33F24G0540, 33F24J0331, 33F24J0654, 33F25E0261, 33F25H0168, 33F25J0937, 33F25L0478, 33F24K0286
19108019022103851080190221021710801902210385WJ-05401/10801902210385, 10801902210217, 10801902210385/33F24B0166, 33F24C0054, 33F24J0672, 33F24K0307, 33F24L0548, 33F25A0609, 33F25A0625, 33F25C0723, 33F25E0285, 33F25E1062, 33F25G0156, 33F25H0187, 33F25J0640, 33F25J0952, 33F25L0414, 33F26B0559, 33F26C0858
20108019022102171080190221485710801902209853ASK-05501-USC1/10801902210217, 10801902214857, 10801902209853/33F24E0506, 33F24E0507, 33F24G0478, 33F24L0561, 33F25A0561, 33F25C0167, 33F25C0769, 33F25E0200, 33F25G0132, 33F25H0745, 33F25J0908, 33F25L0412, 33F26B0557, 33F24C0211
Amount recalled
205,685

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

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