BEUDAMED
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    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

    FDA Enforcement
    Class II ·Ongoing·Covidien, LLC·July 5, 2023

    HemosIL ReadiPlasTin, Part No. 0020301400

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·May 18, 2022

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·October 27, 2021

    HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·October 27, 2021

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: 011-CH3266; 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Purple Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: 011-CH3446; 61 cm (24") Appx 8.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros w/Purple Cap, 3 Clamps (1 Blue, 2 White), Check Valve, Dry Spike Adapter, REF: 011-CH3729; 25 UNITS of Spiros CLOSED MALE LUER, REF: 011-H2457; Appx 1.0 ml, Adattatore per Pompa con Spiros, REF: 011-H2629; 179 cm (70") Appx 11.5 ml, PUR Ambr. Deflussore con Spiros, Camera, BCV, Y-Clave e LL Gir., REF: 011-H2776; 180 cm (71IN)APPX 11.5ml,PUR AMBR,Spiros,CAMERA,REG.FLUSSO,BCV,Y-Clave, REF: 011-H2864-HSR; 181cm(71 IN)APPX11.6ml,PUR DEFLUSSORE,Spiros,20 DROP IN LINE,BCV,Clave, REF: 011-H2904; 38 cm (15 IN) APPX 2.9 ml, TRIFUSE EXT SET, 3 MicroClave, Spiros, PURPLE CAP, REF: 011-H3449; 42cm(16.5 IN)APPX 2.6ml,PUR TRANSFER SET,Clave ADDITIVE PORT,BCV,Spiros, REF: 011-H3597; 41cm(16 IN)APPX 2.9ml,PUR SET PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3628; 41cm(16 IN)APPX 3.1ml,SET AMBRATO,PERFORATORE,Clave,VALVOLA,Spiros, REF: 011-H3629; 42cm(16.5 IN)APPX 5.6ml,SET,PERFORATORE,Clave,FILTRO,VALVOLA,Spiros, REF: 011-H3630; 109 cm(43 IN) APPX 7.2 ml,KIT,EXT SET W/Spiros,STOPCOCK,5 Clave,4-GANG STOPCOCK, REF: 011-MC330632; 2 Ext Sets w/5-Gang Stopcock, 9 Clave, Spiros, Stopcock, REF: 011-MC33242; Kit for multiple transfers, REF: 011-N1000; Kit per il riempimento pompe elastomeriche con SPIROS / Kit for elastomeric pump priming with SPIROS, REF: 011-N1000-P2; APPX 2.3ml, ZYTO-VERBINDUNGSLEITUNG (ZYTO-CONNECTING LINE), REF: 011-N1664SP; Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros, REF: 034-H2629; Spinning Spiros Closed Male Luer, Red Cap (No Flange), REF: CH2000S-NR; 15" (38 cm) Appx 5.2 ml, Bifuse Add-On Set w/Bag Spike, Spiros, 3 Clamps (Blue, 2 White), Dry Spike Adapter, REF: CH3187; 14" (36 cm) Appx 8.0 ml, Quinfuse Add-On Set w/4 Spiros, Bag Spike, 5 Clamps (Blue, 4 Red), Dry Spike Adapter, REF: CH3225; 20" (51 cm) Appx 9.5 ml, Quadfuse Add-On Set w/3 Spiros, Bag Spike, 4 Clamps (Blue, 3 Red), Dry Spike Adapter, REF: CH3226; 16" (41 cm) Appx 6.3 ml, Trifuse Add-On Set w/2 Spiros, Bag Spike, 3 Clamps (Blue, 2 Red), Dry Spike Adapter, REF: CH3227; 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros, REF: CH3235; 28" (71 cm) Appx 5.1 ml, Add On Set w/Clave Spike, Spiros, Clamp, REF: CH3354; 16cm(6 IN)APPX 2.4ml,SET,MicroClave Clear,STOPCOCK,DROP-IN ADD-ON,Spiros, REF CH3411: APPX 1.9 ml,13 cm (5 IN),BAG SPIKE,Spiros,ACCESS DEVICE w/Clave, REF: CH3502; 60 (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Low Protein Binding Filter, Spiros w/Red Cap, Clamp, REF: CH3603; Spinning Spiros Closed Male Luer, REF: K7040-001; APPX 0.76ml, 4-WAY STOPCOCK w/2 Clave, VIAL ADAPTER, 3 Spiros, REF: K7052-001; ZYTOmed Verab.-Set Onko II lichtschutz, REF: SN1205AG; ZYTOmed - Verabreichungs-Set Onko III lichtgesch¿tzt, REF: SN1206A; Conector macho cerrado Spinning Spiros, tapon purpura, REF: 034-CH2000S-PC

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack Number CDS984206R; 7) OPEN HEART PEDS PACK, Pack Number CMPJ01037P; 8) OPEN HEART A&B PACK, Pack Number CMPJ02162I; 9) HMT SMALL TABLE PACK, Pack Number CMPJ03510J; 10) MAJOR VASCULAR PACK, Pack Number CMPJ06631C; 11) VASCULAR PACK, Pack Number CMPJ08949F; 12) BOISE HEART PACK-LF, Pack Number CMPJ09225F; 13) VASCULAR PACK, Pack Number CMPJ09236D; 14) VASCULAR/OR ANGIO PACK, Pack Number CMPJ09236F; 15) CAROTID ENDARTERECTOMY PACK, Pack Number CMPJ09400C; 16) CAROTID PACK, Pack Number CMPJ10797B; 17) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985A; 18) CAROTID ENDARTERECTOMY, Pack Number CMPJ10985B; 19) VASCULAR PACK, Pack Number CMPJ13632; 20) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048M; 21) CABG PACK-LF, Pack Number DYNJ0824648K; 22) HEART PEDIATRIC PACK-LF, Pack Number DYNJ16541R; 23) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 24) ADULT CARDIO TRAY, Pack Number DYNJ35495G; 25) PEDIATRIC CARDIO CATH PACK, Pack Number DYNJ35578G; 26) MAJOR VASCULAR PACK, Pack Number DYNJ38318F; 27) MAJOR VASCULAR PACK, Pack Number DYNJ38318G; 28) EP PACER PACK, Pack Number DYNJ38863N; 29) EP PACER PACK, Pack Number DYNJ38863O; 30) PERFUSION SYRINGE, Pack Number DYNJ39223C; 31) VASCULAR PACK, Pack Number DYNJ39525; 32) VASCULAR ADD ON PACK, Pack Number DYNJ44420C; 33) SHUNT ENDARTERECTOMY, Pack Number DYNJ44565D; 34) VASCULAR ACCESS PACK, Pack Number DYNJ56510A; 35) HEART VALVE PACK, Pack Number DYNJ58365J; 36) RIGHT HEART PACK MOSES, Pack Number DYNJ58873A; 37) GENERAL VASCULAR PACK, Pack Number DYNJ60177A; 38) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904A; 39) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904B; 40) PK CUST PERIPHERAL VASCUL, Pack Number DYNJ60904C; 41) PK, VASCULAR-MAJOR, Pack Number DYNJ61603A; 42) VASCULAR PACK, Pack Number DYNJ63182A; 43) VASCULAR SHARED, Pack Number DYNJ64801B; 44) VASCULAR PACK, Pack Number DYNJ65160; 45) VASCULAR DSC, Pack Number DYNJ69172B; 46) OPEN HEART PACK, Pack Number DYNJ83695; 47) WMC HYBRID OR, Pack Number DYNJ904036J; 48) VASCULAR, Pack Number DYNJ904845G; 49) BOISE HEART, Pack Number DYNJ905070I; 50) VASCULAR/OR ANGIO, Pack Number DYNJ905079F; 51) VASCULAR PACK, Pack Number DYNJ905226D; 52) CAROTID, Pack Number DYNJ906561F; 53) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744A; 54) CAROTID ENDARTERECTOMY, Pack Number DYNJ906744B; 55) UNIVERSITY VASCULAR, Pack Number DYNJ907201B; 56) KIT OPEN HEART, Pack Number DYNJ908603B; 57) VASCULAR PACK, Pack Number DYNJ909374; 58) ISLET CELL UNIV OF IL, Pack Number DYNJ909768; 59) ADULT CORONARY PACK, Pack Number DYNJV0275J; 60) ADULT CORONARY PACK, Pack Number DYNJV0275K; 61) ADULT CORONARY PACK, Pack Number DYNJV0275M; 62) ADULT CORONARY PACK, Pack Number DYNJV0275N

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    Change Healthcare Cardiology Hemodynamics software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Change Healthcare Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    McKesson Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024

    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: 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: 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

    Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·May 26, 2021

    Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    Penner Pacific Bathing Spa, Model Numbers 860010-1L

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026