11 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: 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
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: 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
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: 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
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: 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
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: 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
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026