60 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
FDA Recall
Terminated
·Medline Industries Inc·Product code FDE·January 21, 2020
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·March 4, 2020
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·August 18, 2021
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·August 18, 2021
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·January 1, 2020
Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Surgical Vision Inc·July 10, 2019
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·October 28, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
FDA Recall
Terminated
·Stryker Endoscopy·Product code FAT·August 20, 2009
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code DQO·March 20, 2009
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set.
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·October 20, 2009
PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code CHH·February 20, 2009
OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009
Stryker CBCII ConstaVac Blood conservation system, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009
Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009
Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile Stryker Instruments, Kalamazoo, MI, REF 225-28-85S4. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009
Stryker CBCII collection only pkg/6, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-S20. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009
Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-626S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009