ARROW INTERNATIONAL, LLC recalls Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH
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
- CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH
CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F
CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F
3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH
3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM
3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH
MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A
PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC
PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC
CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553
2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A
2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A
2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A
2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A
3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A
3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A
CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC
CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F
CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402
CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502
CVC KIT: 16 GA X 8IN/AK-24301-SK
CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402
CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK
CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC
CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F
CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402
CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502
CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553
LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A
LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A
CVC KIT: 16 GA X 20 CM/CDC-24301-1A
PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A
PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A
CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR
MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH
PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1
MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2
PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1
PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2
MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1
MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A
CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1
PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH
PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM
PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A
PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A
PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2
MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1
PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1
PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB
MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM
PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH
MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2
PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM
MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL
PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1
PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1
PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1
MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA
MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A
PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A
PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH
PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2
CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM
MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM
PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2
MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1
MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A
PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A
CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4
PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A
PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A
PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A
PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A
PI CVC KIT: 2-L 8 FR X 20 CM AGB
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185 — +675 moreShow all
(Batch): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325, 33F25B0672, 33F25E0653, 33F25E0877, 33F25M0114, 33F25M0424, 33F26A1508, 33F25A0326; CDC-22123-X1A/10801902193275, 20801902116851, 20801902116851,10801902213591/33F25B0673, 33F25D0446, 33F25D0667, 33F25F0212, 33F25G0413, 33F25J0317, 33F25M0396, 33F26B0442, 33F24D0842; CDC-24301-1A/30801902116902, 10801902193275, 30801902116902, 30801902116919/33F24D0874, 33F24F0076, 33F24F0863, 33F24K0501, 33F24L0979, 33F25B0617, 33F25D0494, 33F25D0668, 33F25E0697, 33F25E0820, 33F25H0571, 33F25J0249, 33F25K0181, 33F25L0084, 33F25L0104, 33F26A1413, 33F26B0784, 33S25E0697, 33F24C0702; AK-22702-P1A/10801902193275, 30801902122378/33F25D0322, 33F25H0424, 33F25J0097, 33F25K0085, 33F24E0364; CDC-22702-XP1A/10801902193275, 30801902116896/33F25D0451, 33F25F0217, 33F25H0573, 33F25J0322, 33F26A1386, 33F26B0706, 33F25K0180; ASK-45703-CPR/10801902193275/33F24J0477, 33F24L1068; ASK-42703-AKP1A/10801902193275, 10801902202519/33F24J0324, 33F25A0577, 33F25C0841, 33F25E0233, 33F25E1027, 33F25G0140, 33F25H0148, 33F25H0754, 33F25J0924, 33F25M0869, 33F24F0754; ASK-42703-KH/10801902193275, 10801902205657/33F24G0269, 33F24L0087, 33F25E0235, 33F25G0141, 33F25L0213, 33F24D0891; ASK-42703-MGH1/10801902193275, 10801902223682, 10801902193275/33F25J0735, 33F26C0344, 33F25E0509; ASK-42703-PCCH2/10801902193275, 10801902141030/33F24L0231, 33F24L0416, 33F24L0945, 33F25B0443, 33F25B0561, 33F25D0352, 33F25E0726, 33F25G0316, 33F25J0155, 33F25M0013, 33F26B0792, 33F26C0228, 33F25D0540; ASK-42703-PFS1/10801902193275/33F25E0598, 33F25B0275; ASK-42703-PNO2/10801902193275/33F26A1661, 33F24L0335; ASK-42703-PSCH1/10801902137330, 10801902193275/33F24F1038, 33F24H0204, 33F25B0566, 33F25H0491, 33F25J0274, 33F25M0092, 33F26B0124, 33F24H0100; ASK-42802-AKP1A/10801902193275, 10801902217155/33F24G0511, 33F24K0264, 33F24L0745, 33F25C0931, 33F25H0150, 33F25J0561, 33F25L0481, 33F25M0971, 33F24F0676; ASK-42802-LMDTG1/10801902193275, 10801902205701/33F26A1254, 33F26B0814, 33F24H0215; ASK-42802-PUCI1/10801902193275/33F24L0195; ASK-42802-PUMH/10 …
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-2376-2026
- FDA 510(k) clearance · K071538The device's official FDA premarket clearance record
- FDA 510(k) clearance · K900263The device's official FDA premarket clearance record
- FDA 510(k) clearance · K970864The device's official FDA premarket clearance record
- FDA 510(k) clearance · K993691The device's official FDA premarket clearance record
- 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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