19 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1 PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1 PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1 PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1 PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1 AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A
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: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·February 22, 2023
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·February 22, 2023
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·May 24, 2023
HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·February 22, 2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·March 1, 2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
FDA Enforcement
Class II
·Ongoing·Access Vascular, Inc·March 1, 2023
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·December 27, 2023
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Enforcement
Class I
·Ongoing·Conavi Medical Inc.·April 30, 2025
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
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
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784
FDA Enforcement
Class I
·Ongoing·Bard Access Systems, Inc.·April 23, 2025
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023