50 Zeilen Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of. Z-0009-2019 - ENDOLOGIX AFXAFX2 Limb Iliac Extension Endograft Rx Only Sterile EO AFX Limb Accessory Model REF.
This database contains Medical Device Recalls classified since November 2002.
Fda medical device recalls. FDA Recall Posting Date. 1-888-INFO-FDA 1-888-463-6332 Contact FDA. Z-1258-2021 - ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System used for infusion of.
Since January 2017 it may also include correction or removal actions initiated by. Medtronic Mechanical Circulatory Support formerly HeartWare Inc Expands Recall for Ventricular Assist Device Controllers and DC Adapter. Class I medical device recalls are the most serious and urgent under FDA classification.
1400 1401 1401AU 1401BR 1401CA 1401CH 1401DE 140. Medtronic HVAD Packaged Monitor Model Numbers. 10903 New Hampshire Avenue Silver Spring MD 20993 Ph.
Alaris Infusion Pump Module Model 8100. Medical Device Recalls. Results per Page New Search Export to Excel Help.
Protek Solo Venous Dilator Set. A 30 mm REF 5-10106 REF 5-10206 b 35 mm REF 5-10107 c 40 mm REF 5-10108 REF 5-10208 d 45 mm REF 5-10109 e 50 mm REF 5-10110 REF 5-10210 f 55 mm REF. Z-2312-2019 - Hudson RCI SheridanCF.
A 2018 CDRH report stated that since 2007 the FDA has increased its number of domestic device inspections by 46. Medtronic HVAD Controller Product Numbers. 9 Zeilen 2021 Medical Device Recalls.
1500 1500AU 1500DE 1510US 1511AR 1511AU 1511B. Vaccines Blood. Recalls Alaris System PC Unit and PC Unit.
Medtronic Recalls Valiant Navion. -crystalloid colloid or blood product including. Medtronic Recalls HeartWare Splice.
BA22-120I20-40 BA22-100I20-40 BA22-80I20-40 BA22-60I20-40. In a recent three-month period 18 devices were recalled or an average of 15 products recalled each week. Databases - 1 result found 510K Number.
Medical Device Recalls. When failures occur the company selling the device will often have to step in and publicly recall all affected copies or at the. The FDA has identified this as a Class I recall the most serious type of recall.
1-888-INFO-FDA 1-888-463-6332 Contact FDA. Medical device failures and malfunctions invariably harm peoples wellbeing due to the fact they are often deployed on the frontline of patient care and in users homes. Use of these devices may cause serious injuries or death.
10903 New Hampshire Avenue Silver Spring MD 20993 Ph. The FDA issues a statement for each device recall. 34 Zeilen Becton Dickinson BD CareFusion 303 Inc.
Z-0006-2019 - ENDOLOGIX AFX Endovascular AAA System Stent Graft System Rx Only Sterile EO REF.
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