ARROW INTERNATIONAL, LLC recalls Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH
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
- PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4
PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4
PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1
PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2
MULTI LUMEN/PSI KIT/ASK-11142-NSU
MULTI-LUMEN/PSI KIT/AK-21242-X
MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC
MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1
MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5
MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT
2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1
2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1
MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A
MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A
MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A
MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A
2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1
2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3
2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3
MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2
MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1
2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1
AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1
MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1
MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2
AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1
PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1
PSI KIT: 9 FR/ASK-29903-MHI
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4
PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4
PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1
PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A
PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH
PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A
PSI ACCESS TRAY/ASK-04001-MM2
MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC
MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3
Lot / code information
- REF
- (Material)/UDI-DI/
- Lot #
(Batch): ASK-09701-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039 — +633 moreShow all
(Batch): ASK-09701-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039, 33F25L0133, 33F26B0369, 33F23K0811; ASK-09803-OSU4/10801902212075, 10801902193275/33F24F0994, 33F24K0428, 33F25B0183, 33F25D0761; ASK-09903-AMC1/1080190219327, 10801902161830, 10801902136678/33F25A0437, 33F25E0024, 33F25G0690, 33F25L0142, 33F26C0117, 33F24B0612; ASK-09903-CMC1/10801902136678, 10801902193275/33F24D0050, 33F24D0965, 33F24F0130, 33F24J0321, 33F24J0627, 33F24L0585, 33F25A0110, 33F25C0176, 33F25C0588, 33F25E0212, 33F25E1020, 33F25F0324, 33F25G0753, 33F25L0208, 33F26A0396, 33F26A1255, 33F25E0716; ASK-09903-OSU4/10801902212006, 10801902193275/33F24G0022, 33F24L0298, 33F25D0762; ASK-09903-PCMH1/10801902193275, 20801902115205/33F25L0139, 33F26B0136, 33F24H0108; CDC-09803-1A/50801902116715, 10801902193275, 60801902116729/33F24D0892, 33F24F0766, 33F24L0274, 33F25B0147, 33F25C0497, 33F25C0498, 33F25D0553, 33F25E0647, 33F25F0209, 33F25H0574, 33F25L0121, 33F25M0410, 33F24D0504; ASK-09903-ECL3/10801902193275/33F25G0241, 33F25H0530, 33F25J0357, 33F26A0015; ASK-11242-PHP2/10801902193275, 10801902196436/33F24J0117, 33F24K0727, 33F25A0009, 33F25E0003, 33F25F0359, 33F25K0040, 33F25L0132, 33F26B0223, 33F26D0016, 33F24K0544; ASK-11142-NSU/10801902182545, 10801902193275/33F24E0326, 33F24K0354, 33F24L0244, 33F24L0300, 33F25B0189, 33F25C0228, 33F25D0467, 33F25E0591, 33F25G0272, 33F25G0405, 33F25H0629, 33F25J0363, 33F26A1572, 33F26B0816, 33F24L0840; AK-21242-X/10801902193275, 30801902122262, 80801902123127/33F24G0358, 33F24J0522, 33F24K0124, 33F24L0749, 33F25B0683, 33F25E0073, 33F25J0479, 33F25L0443, 33F26C0301, 33F24D0371; ASK-21142-DMC/10801902193275, 10801902218930, 10801902206685/33F25B0242, 33F25M0671, 33F26A0237, 33F26B0946, 33F24D0718; ASK-21142-GMC1/10801902193275, 10801902200492/33F25B0642, 33F25E0719, 33F25H0582, 33F25M0147, 33F26C0335, 33F24F0098; ASK-21142-HF5/10801902200492, 10801902193275, 10801902200492/33F24F0921, 33F24K0350, 33F24L0245, 33F25A0168, 33F25C0272, 33F25D0344, 33F25F0103, 33F25G0282, 33F25H0614, 33F25J0371, 33F26A1525, 33F26C0040, 33F24L0309; ASK-21142-LMDT/10801902193275, 10801902220728/33F25A0041, 33F25B0381, 33F25D0346, 33F25F0172, 33F25K0416, 33F25M0343, 33F26B0189, 33F26C0139, 33F25K0206; ASK-21142-UCL1/10801902193275/33F25E0541, 33F25G0391, 33F25J0102, 33F25J0373, 33F25M0235, 33F26A1375, 33F24H0098; ASK-21142-UPMC2/10801902159479, 10801902193275, 10801902225365/33F24F0879, 33F24J0161, 33F24L0310, 33F24L1023, 33F25C0276, 33F25E0780, 33F25G0348, 33F25J0209, 33F26A1371, 33F26A1547, 33R25G0348, 33F26C0490; ASK-21242-SL1/10801902193275/33F26A1347, 33F25E0314; ASK-21242-UMH/10801902129502, 10801902193275, 10801902156348/33F24E0637, 33F24F0895, 33F24L0317, 33F25B0197, 33F25C0280, 33F25D0478, 33F25F0178, 33F25H0564, 33F25L0106, 33F26A1517, 33F24F0618; ASK-21242-UN1/10801902193275, 10801902156348/33F24H0146, 33F25A0438, 33F25D0032, 33F25E0315, 33F25F0236, 33F25H0778, 33F25K0044, 33F26A0252, 33F26B0219, 33F26C0048, 33F25C0816; CDC-21142-XCN1A/10801902196498, 10801902193275/33F24E0226, 33F24E0242, 33F24E0254, 33F24F0250, 33F24G0203, 33F24H0356, 33F24H0391, 33F24J0220, 33F24L0078, 33F24M0018, 33F24M0054, 33F24M0206, 33F25A0130, 33F25A0385, 33F25B0068, 33F25B0340, 33F25C0076, 33F25C0510, 33F25D0697, 33F25D0733, 33F25E1092, 33F25E1101, 33F25F0435, 33F25G0027, 33F25H0334, 33F25H0814, 33F25J1006, 33F25K0310, 33F25L0090, 33F25L0277, 33F26A1615, 33F26A1622, 33F26A1623, 33F26A1645, 33F25B0528; CDC-21142-XN1A/10801902193275, 10801902196504, 50801902116821/33F25D0441, 33F25E0816, 33F25F0210, 33F25J0418, 33F26B0438, 33F26B0809, 33F26C0018, 33F24D0429; CDC-21242-XCN1A/10801902196511, 10801902193275, 10801902196511/33F24D0427, 33F24D0493, 33F24D0502, 33F24E0257, 33F24E0833, 33F24G0147, 33F24G0162, 33F24G0202, 33F24G0249, 33F24G0620, 33F24H0067, 33F24H0330, 33F24H0355, 33F24H0390, 33F24H0423, 33F24H0449, 33F24J0252, 33F24K0013, 33F24K0041, 33F24K0629, 33F24L0158, 33F24M0056, 33F24M0066, 33F24M0091, 33F25A0132, 33F25A0373, 33F25B0028, 33F25B0097, 33F25B0135, 33F25C0217, 33F25C0529, 33F25C0692, 33F25D0690,33F25D0692, 33F25D0698, 33F25D0707, 33F25D0721, 33F25D0734, 33F25D0754, 33F25E0415, 33F25E1102, 33F25E1123, 33F25E1152, 33F25F0030, 33F25F0039, 33F25F0484, 33F25F0525, 33F25H0335, 33F25H0872, 33F25J0747, 33F25J0774, 33F25K0292, 33F25K0353, 33F25L0092, 33F25L0236, 33F25L0298, 33F26A1617, 33F26A1626, 33F26A1632, 33F26A1635, 33F26B0621, 33F26B0622, 33F26B1039, 33F26D0229, 33F26D0230, 33X25J0002, 33F24H0395; CDC-21242-XN1A/10801902193275, 10801902196528, 20801902123484/33F25A0378, 33F25B0029, 33F25B0098, 33F25B0341, 33F25C0420, 33F25C0530, 33F25E1093, 33F25E1124, 33F25H0286, 33F25H0362, 33F25J0775, 33F25J1040, 33F26A1618, 33F26A1627, 33F26C0453, 33F26C0881, 33X25J0001, 33F24F0996; ASK-21142-CO1/10801902214291, 10801902193275/33F24F0767, 33F24K0423, 33F25B0548, 33F25D0266, 33F25F0170, 33F25H0592, 33F25K0136, 33F26A1450, 33F26C0489, 33F24J0113; ASK-21142-FH3/10801902206685, 10801902193275/33F24E0615, 33F24F0988, 33F24K0455, 33F24L0308, 33F24L0896, 33F25A0244, 33F25B0549, 33F25E0539, 33F25F0171, 33F25G0254, 33F25H0607, 33F26A1574; ASK-21142-OHSU3/10801902193275, 10801902188899, 10801902129953/33F25E1194, 33F25G0692, 33F25K0041, 33F25K0422, 33F26B0907, 33F24F0049; ASK-21142-SG2/10801902193275/33F25B0550, 33F25C0274, 33F25E0540, 33F25F0174, 33F25H0533, 33F25J0208, 33F26B0198, 33F26B0786, 33F25G0695; ASK-21142-UOI1/10801902193275, 10801902158878, 10801902159479/33F24J0014, 33F25A0013, 33F25B0425, 33F25E0012, 33F25G0553, 33F25H0773, 33F25K0042, 33F25L0259, 33F26A0236, 33F26C0115, 33F24D0800; ASK-21142-WHC2/10801902193275, 10801902134964/33F25B0643, 33F25D0473, 33F25E0857, 33F25F0114, 33F25J0210, 33F26C0338, 33F24H0148; ASK-21242-BID1/10801902193275, 10801902219135, 10801902220339/33F24L1014, 33F25B0644, 33F25E0594, 33F25F0091, 33F25F0346, 33F25H0454, 33F25J0211, 33F26C0376, 33F24F0067; ASK-21242-BSWH2/10801902220339, 10801902193275, 10801902160987/33F …
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-2369-2026
- FDA device classification · OFCOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1340The 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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