ARROW INTERNATIONAL, LLC recalls Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Description/1 code
- ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302 — +231 moreShow all
(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 10801902193275, 10801902168488/33F24E0342, 33F24F0325, 33F24G0347, 33F24J0512, 33F24K0113, 33F24L0750, 33F25C0109, 33F25C0964, 33F25E0063, 33F25E0926, 33F25J0474, 33F24A0408; AK-12703-CDC/10801902168488, 10801902193275, 10801902168495/33F24A1020, 33F24B0187, 33F24C0104, 33F24D0078, 33F24G0348, 33F24J0513, 33F24K0114, 33F24L0596, 33F25C0110, 33F25C0759, 33F25J0834, 33F25M0948, 33F24A0401; AK-14402/10801902168495, 10801902193275, 10801902168495, 10801902168518/33F24E0177, 33F24E0343, 33F24F0328, 33F24G0349, 33F24J0514, 33F24K0115, 33F25B0369, 33F25C0875, 33F25E0064, 33F25E0928, 33F25H0029, 33F25J0475, 33F26B0564, 33F24A0813; AK-14502/10801902168518, 10801902193275, 30801902122040/33F24E0344, 33F24G0350, 33F24K0116, 33F24L0656, 33F25C0878, 33F25E0065, 33F25G0089, 33F25J0476, 33F26B0568, 33F24A0849; AK-14553/30801902122040, 10801902193275, 10801902122077/33F24B0190, 33F24C0107, 33F24E0345, 33F24E0346, 33F24F0332, 33F24G0351, 33F24K0117, 33F24L0689, 33F25C0112, 33F25C0848, 33F25G0090, 33F25J0835, 33F24B0191; AK-14703-SP/10801902122077, 10801902193275, 10801902197136/33F24E0347, 33F24G0352, 33F24J0516, 33F24K0118, 33F24L0737, 33F25A0476, 33F25C0887, 33F25E0067, 33F25E0929, 33F25J0477, 33F25L0399, 33F25M0905, 33F24D0079; AK-15402/10801902168532, 10801902193275, 10801902168532, 10801902168549/33F24B0194, 33F24E0350, 33F24G0354, 33F24H0034, 33F24J0518, 33F24K0120, 33F24L0751, 33F25A0479, 33F25C0799, 33F25E0069, 33F25E0932, 33F25H0723, 33F25J0836, 33F25L0348, 33F26C0317, 33F24A1268; AK-15553/10801902168549, 10801902193275, 10801902168549, 10801902168563/33F24E0714, 33F24G0226, 33F24G0687, 33F24H0249, 33F24J0353, 33F25B0332, 33F25D0195, 33F25H0796, 33F25J0081, 33F26B0287, 33F24A1269; AK-16402/10801902168563, 10801902193275, 10801902168563, 10801902168570/33F24C0738, 33F24E0715, 33F24H0065, 33F24H0416, 33F24J0212, 33F24J0426, 33F25A0046, 33F25C0087, 33F25C0604, 33F25G0458, 33F25J0082, 33F26A1658, 33F26B0069, 33F26C0446, 33F24A0796; AK-16553/10801902168570, 10801902193275, 30801902122248/33F24E0178, 33F24E0351, 33F24G0355, 33F24J0519, 33F24K0121, 33F24L0790, 33F25C0980, 33F25E0070, 33F25J0478, 33F24C0025; ASK-04301-HH2/10801902193275, 20801902114987/33F25H0640, 33F25K0070, 33F25K0090, 33F24D0733; ASK-12703-MGH3/10801902193275, 10801902115260/33F25D0263, 33F24F0838
What the firm 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: 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.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2377-2026
- FDA 510(k) clearance · K021120The device's official FDA premarket clearance record
- FDA 510(k) clearance · K171146The device's official FDA premarket clearance record
- FDA 510(k) clearance · K810962The device's official FDA premarket clearance record
- FDA 510(k) clearance · K820009The device's official FDA premarket clearance record
- FDA 510(k) clearance · K862056The device's official FDA premarket clearance record
- FDA device classification · DQYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1250The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ARROW INTERNATIONAL, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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