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Sources: EU EUDAMED, US FDA
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FDA Recall
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Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Small AFW Catalog 23226117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Medium AFW Catalog 23136117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Long 33cm Length with Separate Medium AFW Catalog 23236117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
Juxta-Lite compression wrap XL Full Calf Short 28cm Length with Separate Small AFW Catalog 23126117
FDA Recall
Terminated
·Circaid Medical Products Inc·Product code MDR·April 20, 2010
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 28, 2012
AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012
AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump
FDA Recall
Terminated
·Arrow International Inc·Product code MEB·October 2, 2018
Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips Nuclear Medicine, Milpitas, CA 95035
FDA Recall
Terminated
·Phillips Nuclear Medicine·Product code KPS·September 28, 2007
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·August 7, 2014
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.
FDA Recall
Terminated
·Philips Medical Systems·Product code LLZ·September 15, 2011
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·June 11, 2018
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a software application that is installed in Philips Medical System CT scanners.)
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 10, 2007
Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND Newdeal, Lyon, France; Integra, 411 Enterprise Drive, Plainsboro, NJ 08536 Intended to open the UNI-Compression Plate olive, which creates a compression.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code HRS·September 30, 2008
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Recall
Terminated
·Medela Inc. EF Division·Product code FMF·February 13, 2015