Recall Z-2381-2026

Arrow International, LLC · initiated April 21, 2026

Class I Open, Classified

Class I – dangerous or defective products that could cause serious health problems or death

Product

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F

Codes / lots: REF(Material)/UDI-DI/Lot(Batch): AK-12122-F/10801902197129, 10801902193275, 10801902197129, 10801902168464/33F24B0184, 33F24D0076, 33F24F0321, 33F24G0345, 33F24K0111, 33F25A0474, 33F25C0915, 33F25E0061, 33F25E0924, 33F25J0832, 33F25L0404, 33F26B0552, 33F24A0102

Reason for recall

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-determined cause: Nonconforming Material/Component

Action taken

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: Recalls@teleflex.com 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.

Details

Recall number
Z-2381-2026
Initiated
April 21, 2026
Posted by FDA
June 13, 2026
Product code
LFJ – Catheter, Subclavian
Quantity
1,945
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.
Recalling firm
Arrow International, LLC, Morrisville, NC

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2363-2026 Class IPARACENTESIS KIT, REF: AK-00376, ASK-00376-VCULidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2364-2026 Class IDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2365-2026 Class IDescription/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2366-2026 Class IDescription/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2367-2026 Class IDescription/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2368-2026 Class IDescription/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2369-2026 Class IDescription/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2370-2026 Class IDescription/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2371-2026 Class IDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2372-2026 Class IDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1ALidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2373-2026 Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2374-2026 Class IDescription/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2375-2026 Class IDescription/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2376-2026 Class IDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2377-2026 Class IDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2378-2026 Class IDescription/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2379-2026 Class IDescription/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2380-2026 Class IDescription/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2382-2026 Class IDescription/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2383-2026 Class IDescription/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGULidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2384-2026 Class IDescription/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2385-2026 Class IDescription/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2386-2026 Class IDescription/REF: PARACENTESIS KIT/ASK-00376-JHHLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2387-2026 Class IDescription/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2388-2026 Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2389-2026 Class IDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2390-2026 Class IDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2391-2026 Class IDescription/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2392-2026 Class IDescription/REF: ACCESS TRAY/ASK-04001-MC3Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified
Z-2393-2026 Class IDescription/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… 04/21/2026Open, Classified