ARROW INTERNATIONAL, LLC recalls Description/REF: ACCESS TRAY/ASK-04001-JHH
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
- ACCESS TRAY/ASK-04001-JHH
ACCESS TRAY/ASK-04001-LMDTG
PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1
3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2
MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1
MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1
MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH
1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1
CVC KIT: 16 GA X 16 CM/CDC-24306-1A
CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A
LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A
CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1
MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1
PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1
PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1
MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1
MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2
MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2
MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH
MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2
MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1
CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH
CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM
CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1
PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1
PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2
MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2
PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1
PI CVC KIT: 2L 8 FR/ASK-42802-TGH1
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1
CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH
PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH
3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1
MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1
MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1
PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2
PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275 — +1543 moreShow all
(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F25M0388, 33F26B0791, 33F24F0874; ASK-42703-PCSJ2/10801902193275, 10801902211672/33F25H0468, 33F25J0271, 33F26B0389, 33F26C0179, 33S24L0906, 33F25B0445; ASK-42703-PECL2/10801902193275/33F25H0466, 33F25J0272, 33F26A0011; ASK-42703-PGM4/10801902193275, 10801902221824/33F25B0653, 33F25D0541, 33F25J0106, 33F25J0387, 33F25K0140, 33F26B0749, 33F26C0027, 33F25E1195; ASK-42703-PHHN1/10801902193275, 10801902144734/33F25H0486, 33F25K0064, 33F25M0673, 33F26A0249, 33F26B0906, 33F25E0009; ASK-42703-PLC/10801902193275/33F25D0407, 33F25E0791, 33F25F0099, 33F25H0606, 33F26A1393, 33F25E1196; ASK-42703-PMEM/10801902193275, 10801902142167/33F25G0554, 33F25K0054, 33F25L0256, 33F26C0050, 33F24L0418; ASK-42703-PMHC1/10801902193275/10801902135244/33F25E0561, 33F25H0430, 33F25H0638, 33F25J0388, 33F25M0232, 33F26B0135, 33F26B0796, 33F25F0363; ASK-42703-PNHS1/10801902193275, 10801902225495/33F25D0542, 33F25E0599, 33F25H0498, 33F25H0650, 33F26D0066; ASK-42703-POHU2/10801902193275, 10801902212020/33F25E0562, 33F25G0284, 33F25J0389, 33F26A1421, 33F24F0662; ASK-42703-POSU2/10801902193275/33F24K0401, 33F24L0419, 33F24L0949, 33F25B0446, 33F25D0758; ASK-42703-PTJH/10801902193275, 10801902219012/33F24L0190, 33F25A0015, 33F25B0366, 33F25C0658, 33F25E0316, 33F24E0660; ASK-42703-PUCH2/10801902219012, 10801902193275, 10801902219012, 10801902135022/ ASK-42703-PUCI1/33F24F1025, 33F24L0336, 33F24L1009, 33F25B0476, 33F25C0356, 33F25E0021, 33F25F0189, 33F25H0455, 33F25J0275, 33F25K0142, 33F25M0120, 33F26A1518, 33F26B0182, 33F26B0781, 33F24F0850; ASK-42703-PUHC2/10801902193275, 10801902159608/33F25D0353, 33F25E0602, 33F25G0288, 33F25H0635, 33F25J0277, 33F25K0143, 33F26B0386, 33F26C0149, 33F24D0765; ASK-42703-PUMH/10801902129465, 10801902193275, 10801902159592/33F24F0697, 33F24K0709, 33F24L0997, 33F25C0301, 33F25E0677, 33F25J0278, 33F26A0256, 33F26B0789, 33F26C0227, 33F24D0698; ASK-42703-PUPM1/10801902159592, 10801902193275, 10801902225150/33F24F0761, 33F24K0499, 33F24L1074, 33F25B0519, 33F25C0357, 33F25D0354, 33F25D0598 …
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-2384-2026
- FDA device classification · LRSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5200The 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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