35 results
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13ms
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Sources: EU EUDAMED, US FDA
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·December 22, 2017
MAS Omni Immune Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
MAS Omni Immune PRO Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
FDA Recall
Terminated
·GVI Technology Partners·Product code IYX·January 16, 2004
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code GGK·December 19, 2007
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·September 21, 2018
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·January 15, 2015
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
FDA Recall
Terminated
·Baxter Corporation Englewood·Product code NEP·April 8, 2015
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
FDA Recall
Terminated
·Arrow International Inc·Product code DQY·December 22, 2017
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code LON·May 11, 2017
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites, Central venous pressure monitoring, Total parenteral nutrition (TPN), Infusions of fluids, medications, or chemotherapy, and Frequent blood sampling or receiving blood transfusions/blood products.
FDA Recall
Terminated
·Arrow International Inc·Product code FOZ·August 30, 2018
NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709.
FDA Recall
Terminated
·Ohio Medical Corporation·Product code BTA·May 10, 2010
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
FDA Recall
Terminated
·Medela AG Medical Technology Lattichstrasse 4b Baai Switzerland·Product code BTA·December 2, 2020
SSCOR Suction Device Model 2310V
FDA Recall
Terminated
·S S C O R Inc·Product code BTA·January 6, 2005
SSCOR Suction Device Model 2310BV
FDA Recall
Terminated
·S S C O R Inc·Product code BTA·January 6, 2005
Easy Go Vac Aspirator, Model PM65HG. Portable suction unit
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BTA·November 9, 2004
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient.
FDA Recall
Terminated
·Ohio Medical Corporation·Product code BTA·August 14, 2018
SSCOR Suction Device Model 2310BV-230
FDA Recall
Terminated
·S S C O R Inc·Product code BTA·January 6, 2005
Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code BTA·April 25, 2008
NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator
FDA Recall
Terminated
·Neomedix Corp·Product code BTA·May 28, 2007