10 results
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8ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Enforcement
Class II
·Terminated·DeVilbiss Healthcare LLC·October 9, 2013
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
FDA Recall
Terminated
·DeVilbiss Healthcare LLC·Product code JCX·March 7, 2013
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2015
Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg.
FDA Recall
Terminated
·Integrated Orbital Implants Inc·Product code MQU·December 20, 2006
SonarMed AirWave Monitor, Model Number M0001
FDA Recall
Terminated
·SonarMed Inc·Product code OQU·April 17, 2017
Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019
HEMO-10 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
HEMO-7 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 22, 2015
Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pack; l) SCV30OHKWA - Strl **** Open Heart Pack; m) SBA31LVLUM - Sterile Liver Transplant Pack; n) SBA35LTBLQ - Sterile Lung Transplant Pack; o) SCV44CVDEB - Sterile CV Pack; p) SCV22OHMES - Open Heart Pack; q) SCV23AOSFH - Open Heart Part 3; r) SCV43OHHRF - Open Heart; s) SCV24CAGME - CABG Drape Pack; t) SAN12CCKGB - Cardiac Pack; u) SBA13BRBSE - Breast Reduction; v) SCV11CBNYP - CABG G 3; w) SCV11CESLB - C.V. Drape Pack; x) SCV11CGCPR - CABG; y) SCV11CGXXB - CABG Pack; z) SCV11CJICL - Cardiac Major; aa) SCV11CTMUK - C T Set Up; bb) SCV11DPMYG - **** S Drape Pack; cc) SCV11HEMMI - Open Heart A B; dd) SCV11MRCPE - Major Cardiac; ee) SCV11OCNYN - OH CABG; ff) SCV11OHLD2 - Open Heart A&B Pack; gg) SCV11OHNMC - Open Heart; hh) SCV11OPLKC - O P CABG; ii) SCV11VASLB - C V Valve Drape; jj) SCV11VLNYM - G 3 Valve; kk) SCV12OHYHY - Graft and Linen; ll) SCV13AABSV - Aortic Aneurysm; mm) SCV13AMEMJ - Open Heart Pack B; nn) SCV13BBEMC - Cardio-Thoracic Aux; oo) SCV13CB767 - CABG; pp) SCV13OHCAI - Open Heart Pk; qq) SCV13OOBIG - Open Heart Drape; rr) SCV14O1BGO - Open Heart Pack A; ss) SCV22OHPGA - Open Heart Pack; tt) SCV22OOMSE - Open Heart Preferred; uu) SCV24OH20A - Open Heart Drape Pack; vv) SCV43DREJI - Open Heart Drape Pack; ww) SCV69OH17E - Open Heart; xx) SCV59HVSGJ - Heart Valve Pack; yy) SCV59OHNVM - Open Heart Pack; zz) SCV53HTDMG - ***** Open Heart; aaa) SCV56CH11A - Open Heart Pack; bbb) SCV59MJTCW - Open Heart Pack; ccc) SCV52OH97F - Open Heart Pack; ddd) SCV41OHHIE - Open Heart Pack; eee) SCV52HTSJE - Open Heart Pack; fff) SCV59OHMHV - Basic Heart Pack; ggg) SCV11MJTJI - Open Heart
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 27, 2006