ARROW INTERNATIONAL, LLC recalls Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
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
- RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A
ARTERIAL LINE KIT/AK-04510-S
ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC
ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1
RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR
ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4
RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3
RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR
ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH
ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4
ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2
ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1
ARTERIAL LINE KIT/ASK-04510-FEM1
ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH
ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4
ARTERIAL LINE KIT/ASK-04510-SE
ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2
RA CATH KIT: 20 GA X 12 CM/NA-04550-1A
RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A
RA CATH KIT: 18 GA X 1-3/4IN/AK-04018
RA CATH KIT: 20 GA X 1-3/4IN/AK-04020
RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C
RA CATH KIT: 20 GA X 1-1/2IN/AK-04120
RA CATH KIT: 22 GA X 1-3/8IN/AK-04122
RA CATH KIT: 20 GA X 1-1/2IN/AK-04220
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH
RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS
ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2
RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1
ARTERIAL CATHETERIZATION KIT/ASK-04020-CR
ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2
RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2
RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM
RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1
RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP
RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE
RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM
RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1
RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1
RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI
RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC
RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1
RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU
RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1
RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A
CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1
ARTERIAL ACCESS TRAY/ASK-04001-BW2
ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1
ARTERIAL LINE KIT/ASK-04510-HUM
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052 — +833 moreShow all
(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E0696, 33F24L0051, 33F25A0353, 33F25B0078, 33F25D0714, 33F25G0732, 33F25J0593, 33F26B0039, 33F24A1251; AK-04020/10801902190939, 10801902193275, 60801902121549, 10801902121551/33F24C0727, 33F24C1254, 33F24D0439, 33F24E0697, 33F24F0010, 33F24G0049, 33F24G0116, 33F24G0220, 33F24G0645, 33F24G0646, 33F24G0680, 33F24H0064, 33F24J0013, 33F24J0457, 33F24K0033, 33F24M0004,33F24M0052, 33F24M0070, 33F24M0103,33F24M0146,33F25A0084, 33F25A0335, 33F25A0346, 33F25A0362, 33F25A0397, 33F25B0080, 33F25B0307, 33F25B0414, 33F25C0058, 33F25C0097, 33F25C0494, 33F25C0575, 33F25D0027, 33F25D0083, 33F25D0102, 33F25D0296, 33F25D0703, 33F25F0293, 33F25F0398, 33F25G0493, 33F25H0322, 33F25H0842, 33F25J0037, 33F25J0767, 33F25K0276, 33F25L0154, 33F25L0169, 33F25L0218, 33F26A1264, 33F26A1290, 33F26A1313, 33F26B0291, 33F24C0728, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054, 33F23M0173; AK …
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-2368-2026
- FDA device classification · OFBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1330The 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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