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Class IOngoingZ-2385-2026

ARROW INTERNATIONAL, LLC recalls Description/REF: ACCESS TRAY/GU-04020

ARROW INTERNATIONAL, LLCMorrisville, NC, United StatesReported Jun 24, 2026 · 4 months ago
Legal News Analyst ·

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/GU-04020

PSI KIT: 8.5 FR/AK-09803-CDC

PSI KIT: 9 FR/AK-09903-CDC

PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1

PSI KIT: 9 FR X 10 CM/ASK-09903-KH

PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1

PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA

PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH

PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL

PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC

PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC

PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4

PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3

MULTI-LUMEN/PSI KIT/AK-11142-SPCS

MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A

MULTI-LUMEN/PSI KIT/AK-11142-D

MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4

MULTI-LUMEN/PSI KIT/NA-11242-CDC

MULTI-LUMEN/PSI KIT/AK-21142-SK

MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG

MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH

MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC

MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG

MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD

MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3

MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU

MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A

MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A

MULTI-LUMEN/PSI KIT/AK-21242-CDC

2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4

MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1

2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU

2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4

MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL

MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF

MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1

PSI KIT: 8.5 FR/AK-29803-CDC

PSI KIT: 9 FR/AK-29903-CDC

PSI KIT: 9 FR/AK-29907-CDC

PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1

PSI KIT: 9 FR/ASK-09903-UM

PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT

PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG

PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1

PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG

PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD

PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1

PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A

PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL

PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3

PSI KIT: 9 FR X 10 CM/ASK-29903-ECL

PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3

PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

Lot / code information

REF
(Material)/UDI-DI/
Lot #
(Batch): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154 — +469 moreShow all
(Batch): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036; AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239; AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386; ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109; ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184; ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625; ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787; ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110; ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188; NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327; NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113; ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534; ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780; AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075; CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001; AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252; ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736; NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271; AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023; ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007; ASK-21142-RH/10801902193275/10801902129953/33F24J0108, 33F24L0165, 33F24M0172, 33F25B0422, 33F25E1172, 33F25H0776, 33F25K0424, 33F26C0337, 33F25A0245; ASK-21242-IMC/10801902193275, 10801902118407/33F24G0500, 33F24J0631, 33F24K0255, 33F24L0609, 33F25A0572, 33F25E0223, 33F25H0142, 33F25J0921, 33F26B0543, 33F25C0696; ASK-21242-LMDTG/10801902193275, 10801902220827/33F25G0202, 33F25H0414, 33F25K0382, 33F25M0130, 33F26C0378, 33F24H0123; ASK-21242-UMD/10801902193275/33F24K0476, 33F24L0315, 33F25B0196, 33F25C0279, 33F25D0476, 33F25H0492, 33F25J0378, 33F25M0150, 33F26A1365, 33F25B0551; ASK-21242-UU3/10801902193275/33F24G0503, 33F24L0652, 33F25C0181, 33F25E0226, 33F25H0144, 33F25J0556, 33F24K0077; ASK-21242-VCU/10801902193275, 10801902112962/33F24K0694, 33F25G0171, 33F25H0495, 33F25J0379, 33F26C0494, 33F25C0439; CDC-21242-1A/50801902116821, 10801902193275/33F24D0486, 33F24D0981, 33F24E0227, 33F24F0175, 33F24G0104, 33F24H0296, 33F24H0305, 33F24H0331, 33F24H0357, 33F24H0393, 33F24H0427, 33F24M0019, 33F24M0055, 33F25A0131, 33F25A0367, 33F25B0019, 33F25C0511, 33F25D0706, 33F25E0417, 33F25E1122, 33F25F0416, 33F25G0066, 33F25G0476, 33F25G0711, 33F25H0852, 33F25J0964, 33F25K0352, 33F25L0229, 33F26A1614, 33F26A1624, 33F26A1649, 33F24H0332; CDC-21242-X1A/10801902193275, 30801902116834, 10801902196511/33F25J0291, 33F25J0672, 33F25J0678, 33F25J0690, 33F25J0700, 33F25J0708, 33F25J0724, 33F25L0067, 33F26A1616, 33F26A1625, 33F26B0642, 36F25B0014, 36F25E0020, 36F25G0029, 36F25H0016, 36F25J0005, 33F24C0518; AK-21242-CDC/30801902122255, 10801902193275, 30801902122262/33F24E0082, 33F24E0083, 33F24J0521, 33F24K0123, 33F24L0618, 33F25A0481, 33F25C0946, 33F25E0072, 33F25H0031, 33F25K0037, 33F25K0414, 33F25L0372, 33F26B0520, 33F26C0626, 33F24E0352; ASK-21142-FH4/10801902193275/33F24L0683; ASK-21142-GH1/10801902193275/33F25C0180, 33F25E1023, 33F25H0141, 33F25H0752, 33F25J0920, 33F25L0455, 33F25B0276; ASK-21142-SUU/10801902193275/33F25J0096, 33F25C0275; ASK-21142-UPMC4/10801902193275/33F25A0247; ASK-21242-UKL/10801902114065, 10801902193275, 10801902136487/33F24F0710, 33F24K0467, 33F24L0314, 33F25B0195, 33F25C0278, 33F25D0475, 33 …

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 details

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.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

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
Legal News Analyst

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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