314 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA Recall
Terminated
·bioMerieux·Product code LJC·August 6, 2003
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·May 15, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK-LF, Model Number DYNJ66271D; k) VASCULAR PACK, Model Number DYNJ66356F; l) VENOUS PACK, Model Number DYNJ66499A; m) VENOUS PACK, Model Number DYNJ66499B; n) VEIN PACK, Model Number DYNJ66743B; o) AV FISTULA PACK, Model Number DYNJ66916; p) VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A; q) PICC INSERTION TRAY, Model Number DYNJ67415; r) AFCH CVC INSERTION, Model Number DYNJ67534; s) ENS PICC LINE-HEJ-LF, Model Number DYNJ67606; t) VEIN TRAY, Model Number DYNJ69012A; u) PICC PACK, Model Number DYNJ69088; v) PICC PACK, Model Number DYNJ69088A; w) VEIN PACK, Model Number DYNJ69091A; x) VEIN PACK, Model Number DYNJ69091B; y) VEIN PACK, Model Number DYNJ69177; z) VEIN ABLATION KIT, Model Number DYNJ69272; aa) VEIN ABLATION PACK, Model Number DYNJ69288; bb) BASIC VEIN PACK, Model Number DYNJ69426; cc) VASCULAR VEIN PACK, Model Number DYNJ69769; dd) BCH VEIN ABLATION, Model Number DYNJ69796; ee) VEIN PACK, Model Number DYNJ69942A; ff) FISTULA SAVANNAH PACK, Model Number DYNJ69943; gg) VEIN CLOSURE PACK, Model Number DYNJ69976; hh) VEIN CLOSURE PACK, Model Number DYNJ69976A; ii) VENCLOSE PROCEDURE PACK, Model Number DYNJ80123; jj) VENOUS PACK, Model Number DYNJ80169; kk) VENOUS PACK, Model Number DYNJ80169A; ll) CVR ENDOVENOUS PACK, Model Number DYNJ80643; mm) VENOUS PACK, Model Number DYNJ80692; nn) VENOUS PACK, Model Number DYNJ80692A; oo) VEIN PACK, Model Number DYNJ81120; pp) VEIN PROCEDURE PACK, Model Number DYNJ81177; qq) VEIN PACK, Model Number DYNJ81212A; rr) SUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267; ss) OR VASCULAR ANGIO PACK, Model Number DYNJ81592; tt) PARAGON VEIN PACK, Model Number DYNJ81669; uu) PARAGON VEIN PACK, Model Number DYNJ81669B; vv) ANGIOGRAM-DECH-LF, Model Number DYNJ81725; ww) PICC-DECH-LF, Model Number DYNJ81726; xx) VEIN CLOSURE PACK, Model Number DYNJ81834; yy) VEIN PACK, Model Number DYNJ82033; zz) VEIN PACK, Model Number DYNJ82033A; aaa) SUPERFICIAL VENOUS PACK, Model Number DYNJ82100; bbb) SUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101; ccc) VEIN PROCEDURE TRAY, Model Number DYNJ82581; ddd) VARICOSE VEIN PACK, Model Number DYNJ82884; eee) VARICOSE VEIN PACK, Model Number DYNJ82885; fff) LASER VEIN EC PACK, Model Number DYNJ82951; ggg) SUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989; hhh) PORT DIALYSIS PACK, Model Number DYNJ83087; iii) DEXMED ACCESS PACK, Model Number DYNJ83148; jjj) VEIN TRAY, Model Number DYNJ83384A; kkk) RADIO VEIN ABLATION PACK, Model Number DYNJ83534; lll) VEIN PACK, Model Number DYNJ83747; mmm) VEIN ABLATION PACK, Model Number DYNJ83846; nnn) VEIN PACK, Model Number DYNJ83914; ooo) VEIN PACK, Model Number DYNJ83935; ppp) VEIN ABLATION PACK, Model Number DYNJ83974; qqq) VENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I; rrr) VASCULAR ACCESS-LF, Model Number DYNJ905285D; sss) GENERAL AV FISTULA, Model Number DYNJ906011B; ttt) KIT VEIN ABLATION, Model Number DYNJ907381; uuu) OPEN VASCULAR UE, Model Number DYNJ907858; vvv) PICC LINE TRAY-LF, Model Number DYNJT2272J; www) PICC LINE TRAY-LF, Model Number DYNJT2272K; xxx) PICC CUSTOM PACK, Model Number GSS584Q; yyy) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A; zzz) PEDS/ NICU LINE KIT, Model Number MNS13555; aaaa) ER CENTRAL LINE KIT, Model Number P155508D; bbbb) PICC INSERTION TRAY, Model Number PICC0018; cccc) PICC TRAY, Model Number PICCNC0008; dddd) PQ PICC LINE PACK, Model Number PICCNC0013; eeee) STANDARD PICC II-LF, Model Number
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·May 18, 2023
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROTOMY PACK-LF, REF DYNJ0311538N; 77) LAPAROTOMY PACK-LF, REF DYNJ0366425N; 78) MAJOR PACK-LF, REF DYNJ0386381L; 79) DONOR FREE FLAP PACK-LF, REF DYNJ0426069N; 80) LAPAROSCOPY GYN PACK, REF DYNJ05175M; 81) LAPAROTOMY PACK-LF, REF DYNJ0519288N; 82) MINOR PACK-LF, REF DYNJ0531958S; 83) MAJOR PACK-LF, REF DYNJ0531964X; 84) LAP CHOLE PACK-LF, REF DYNJ0537278AD; 85) LAP/CHOLE PACK-LF, REF DYNJ0589896R; 86) LAP/CHOLE PACK-LF, REF DYNJ0589896S; 87) LAP/CHOLE PACK-LF, REF DYNJ0589896T; 88) LAP/CHOLE PACK-LF, REF DYNJ0589896U; 89) LAP/CHOLE PACK-LF, REF DYNJ0589896V; 90) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913K; 91) LAKELAND LAP CHOLE PACK-LF, REF DYNJ0619913M; 92) LKLND LP CHL PK RFID-LF, REF DYNJ0619913N; 93) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401Q; 94) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401R; 95) MINOR ABDOMINAL PACK-LF, REF DYNJ0751401S; 96) MAJOR LAPAROTOMY PACK-LF, REF DYNJ0751444S; 97) MAJO
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·October 9, 2024
i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CHL·February 23, 2009
Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CHL·March 30, 2004
i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·January 1, 2008
Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CHL·September 22, 2003
ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device).
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·January 18, 2008
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·July 5, 2012
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·November 21, 2019
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·March 10, 2020
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code CHL·December 22, 2020
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CHL·November 22, 2024
i-STAT EG6+ cartridge; List Number: 03P77-25;
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·April 16, 2009
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CHL·March 30, 2004
GEM Premier 4000 Laboratory Analyzer
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code CHL·March 27, 2007
Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·September 19, 2005
ABL 800 FLEX series blood gas analyzers containing software version 5.24.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·November 13, 2006