ARROW INTERNATIONAL, LLC recalls Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A
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
- MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A
AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A
AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A
AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB
AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB
AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC
PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK
PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB
PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC
PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB
PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB
PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB
PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC
PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB
PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC
PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB
AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS
AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS
AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS
PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG
PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS
PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH
AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC
AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC
AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC
AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB
AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC
PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS
PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC
PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB
PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC
PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB
PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC
PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC
PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC
AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2
PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1
PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1
AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB
ACCESS TRAY/ASK-04001-NWM
ACCESS TRAY/ASK-04001-VCUH3
PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS
PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS
ACCESS KIT/ASK-04001-BWK2
ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD
MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM
CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB
2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A
LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A
CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR
CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2
CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1
PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1
MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1
PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1
PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1
MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3
PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1
MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC
PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1
PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC
PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1
PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH
MULTI LUMEN CVC KIT: 3L
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275 — +499 moreShow all
(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25J0198, 33F26B0228, 33F26B0831, 33F26C0534; CDC-34041-VPS/10801902193275/33F24L0236; CDC-35052-VPS/10801902193275/33F25E0425; ASK-04001-BWK2/10801902193275/33F25A0226, 33F25D0389, 33F25E0519, 33F25F0076, 33F25F0139, 33F25H0660, 33F25J0347, 33F26A1341; ASK-04001-DU11/10801902193275/33F25C0425, 33F25D0328, 33F25F0140, 33F25H0506; ASK-42703-PVD/10801902156966, 10801902193275/33F24F0977, 33F24L1004, 33F25C0302, 33F25K0144, 33F26B0157; ASK-12703-LMDTG1/10801902193275, 10801902205688/33F25D0262, 33F25G0280, 33F26B0212; ASK-15703-ECMC4/10801902159950, 10801902193275/33F24E0649, 33F24F1039, 33F25B0439; ASK-15703-PNM/10801902193275/33F25E0312; ASK-22123-UAB/10801902144956, 10801902193275/33F24F0854, 33F24L0318, 33F25C0281, 33F25D0267, 33F25D0593, 33F25J0380; CDC-24402-X1A/10801902193275, 10801902168099/33F24L1111, 33F25C0206, 33F25E0747, 33F25G0341, 33F25H0554, 33F25J0324, 33F26A1561, 33F26B0165, 33F26B0803; CDC-25123-X1A/10801902193275, 10801902168105/33F25B0675, 33F25D0501, 33F25E0887, 33F25G0379, 33F26A156 …
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-2394-2026
- FDA device classification · OWLOfficial 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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