FDA Device recall Z-2394-2026

Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A

FDA Device
Class I
ongoing
Published 2026-06-24

On 2026-06-24 the FDA classified a Class I recall of Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A by Arrow International, citing 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 rep….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2394-2026
Classification	Class I
Status	ongoing
Initiated	2026-04-21
Published	2026-06-24
Last updated	2026-09-13 11:58 UTC
Company	Arrow International
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	REF(Material)/UDI-DI/Lot(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; C… 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, 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,

code_info

REF(Material)/UDI-DI/Lot(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; C…

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, 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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2394-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.