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Sources: EU EUDAMED, US FDA
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Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·June 8, 2018
RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·December 19, 2019
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·October 8, 2020
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZC·August 5, 2021
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code KNX·July 11, 2016
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
FDA Recall
Completed
·C.R. Bard, Inc.·Product code EYZ·March 9, 2017
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·July 17, 2025
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code MJC·August 5, 2021
Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZL·August 5, 2021
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code KOD·September 20, 2022
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code EZL·June 18, 2025
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
FDA Recall
Terminated
·C.R. Bard, Inc.·Product code MJC·December 18, 2015