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ARROW recallZ-2364-2026 · Arrow International, LLC · initiated Apr 21, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 4/21/2026, correction notices (Firm Event Number: EIF-000608, lidocaine and bupivacaine) were mailed to customers who were asked to do the following: Arrow International LLC is voluntarily recalling product due to the Huons Co. Ltd. recall of Lidocaine and Bupivacaine, which is included in impacted Arrow Kits & Sets. Medical facilities 1. Provide this correction notice to all persons who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2. Check your inventory for product within the scope of this Medical Device Notification and place a copy of this notice with all affected product. 3. Complete and return the response form virtually via: https://fca.myteleflex.com/en/recall/000608 Distributors: 1. Provide Medical Device Notification to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. 2. Check your inventory for affected product. Place a copy of this notification with all affected product and ensure that the notification is included with future distributions of affected product. 3. Complete and return the response form via link: https://fca.myteleflex.com/en/recall/000608 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email. If you have questions contact firm's Customer Service: Link: https://fca.myteleflex.com/en/recall/000608, Customer Service: Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: [email protected] On 5/29/2026, additional amended notices (Firm Event Number: EIF-000608-01) were mailed to include additional affected devices. On 5/1/2026, additional notices (Firm Event Number: EIF-000609, sodium chloride) were mailed and emailed to customers who have 0.9% sodium chloride (10mL saline solution ampule) in kits and sets.

Recall details

Recall number
Z-2364-2026
Status
Open, Classified
Initiated by the company
Apr 21, 2026
Posted by the FDA
Jun 13, 2026
Recalling firm
Arrow International, LLC
Quantity
205,685
Product code
CAZ
FDA submissions
K001587, K103658, K121403, K122027, K801912, K884552
Distribution
US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

Product description

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

REF(Material)/UDI-DI/Lot(Batch): ASK-04001-SUH-S/10801902210217, 10801902193275/33F25C0766, 33F25E0112, 33F25G0101, 33F25H0058, 33F25H0725, 33F25J0862, 33F25M0836, 33F25F0160; ASK-04001-VM1/10801902210217, 10801902202106, 10801902193275/33F24L0599, 33F26A0962, 33F24G0280; AB-19604-KS/10801902210217, 10801902209471/33F24L0608, 33F25G0474, 33F25J0814, 33F25M0887, 33F24D0064; AB-19608-KS/10801902210217, 10801902209471/33F24E0312, 33F24F0295, 33F24G0316, 33F24K0082, 33F24L0714, 33F25E0027, 33F25E0904, 33F25H0003, 33F25J0815, 33F25L0337, 33F26B0498, 33F24E0314; AB-20608-KS/)10801902210217/33F25H0004, 33F25J0816, 33F24D0437; AB-05060-PK/10801902209433, 10801902210217/33F24D0002, 33F24E0029, 33F24G0315, 33F24J0484, 33F24K0081, 33F25A0451, 33F25C0747, 33F25E0026, 33F25J0646, 33F24E0028; ASK-19609-VCU/10801902210217, 10801902206876, 10801902214291/33F24E0536, 33F24J0630, 33F24L0605, 33F25C0179, 33F25E0220, 33F25H0140, 33F26B1003, 33F24D0628; ASK-19600-CC2/10801902210057, 10801902210217, 10801902210064/33F24D0393, 33F24E0533, 33F24G0494, 33F24K0251, 33F24L0665, 33F25C0177, 33F25E0217, 33F25H0138, 33F24C0230; ASK-19608-CC/10801902210217, 10801902210064, 10801902202236/33F24G0309, 33F24K0252, 33F24L0639, 33F25B0691, 33F25C0178, 33F25C0761, 33F25E0218, 33F25E1022, 33F25H0750, 33F25J0918, 33F26B0230, 33F24D0394; ASK-19608-KP/10801902210217/33F24G0495, 33F24G0086; ASK-19608-SHC/10801902210217, 40801902202220, 10801902202243/33F24G0496, 33F24J0629, 33F24K0253, 33F24L0573, 33F25A0571, 33F25C0733, 33F25E0219, 33F25G0757, 33F25H0139, 33F25J0919, 33F25K0400, 33F25L0480, 33F26B0606, 33F24C0231; FB-19608-K/10801902210217, 10801902210125/33F24G0533, 33F24J0650, 33F24K0279, 33F24L0568, 33F25C0186, 33F25C0748, 33F25E0257, 33F25G0147, 33F25H0164, 33F25J0623, 33F25L0340, 33F25M0847, 33F24C0258; FB-19608-KU/10801902210217, 10801902210132/33F24E0026, 33F24E0574, 33F24G0312, 33F24J0328, 33F24L0557, 33F24M0268, 33F25C0187, 33F25C0940, 33F25E0258, 33F25H0165, 33F25J0624, 33F25L0344, 33F25M0851, 33F23G0580; FB-19609-K/10801902210132, 10801902210217, 10801902210132, 10801902210149/33F24C0259, 33F24D0407, 33F24E0575, 33F24G0534, 33F24K0281, 33F24L0805, 33F25C0721, 33F25E1042, 33F25J0625, 33F25L0351, 33F25M0856, 33F26B0504, 33F24B0386; FB-19609-KU/10801902210149, 10801902210217, 10801902210149, 10801902193275/33F24C0260, 33F24E0576, 33F24E0577, 33F24G0535, 33F24L0763, 33F25A0592, 33F25E0259, 33F25E1043, 33F25H0758, 33F25K0402, 33F25L0471, 33F26B0594, 33F26C0480, 33S24L0763, 33F24L0738; ASK-19608-US1/10801902210217/33F24E0535, 33F24K0254, 33F24L0770, 33F24E0014; ASK-05001-SLR1/10801902210217, 10801902209617/33F24J0596, 33F24L0560, 33F25A0546, 33F25C0939, 33F25E0177, 33F25E0998, 33F25J0530, 33F24C0194; MH-05001/10801902210217/33F24G0540, 33F24J0331, 33F24J0654, 33F25E0261, 33F25H0168, 33F25J0937, 33F25L0478, 33F24K0286; WJ-05401/10801902210385, 10801902210217, 10801902210385/33F24B0166, 33F24C0054, 33F24J0672, 33F24K0307, 33F24L0548, 33F25A0609, 33F25A0625, 33F25C0723, 33F25E0285, 33F25E1062, 33F25G0156, 33F25H0187, 33F25J0640, 33F25J0952, 33F25L0414, 33F26B0559, 33F26C0858; ASK-05501-USC1/10801902210217, 10801902214857, 10801902209853/33F24E0506, 33F24E0507, 33F24G0478, 33F24L0561, 33F25A0561, 33F25C0167, 33F25C0769, 33F25E0200, 33F25G0132, 33F25H0745, 33F25J0908, 33F25L0412, 33F26B0557, 33F24C0211; LG-03000/10801902210217/33F24L0668, 33F24E0581; MTO-03000-VM/10801902210217, 10801902202076, 10801902119916/33F24E0586, 33F24G0547, 33F24J0658, 33F24K0291, 33F24L0632, 33F25A0596, 33F25C0869, 33F25E0265, 33F25H0173, 33F25J0939, 33F25L0380, 33F26C0306, 33F24A1057; SM-03001/10801902210217, 10801902202496, 10801902210354/33F24E0779, 33F24J0243, 33F24J0434, 33F24M0012, 33F25A0099, 33F25B0035, 33F25B0128, 33F25C0410, 33F25C0521, 33F25F0421, 33F25G0531, 33F25J0053, 33F25L0171, 33F26B0643, 33F24C0276; FB-19611-K/10801902210156/33F24F0014

Devices named in this recall

22 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

21 devices cleared under K001587, K103658, K121403, K122027, K801912, K884552 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98793).

Sources and updates

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