48 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Recall
Terminated
·Cardinal Health 200, LLC·Product code LRO·January 31, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
FDA Enforcement
Class II
·Terminated·InfuTronix LLC·July 31, 2019
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·October 27, 2021
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·June 17, 2020
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·June 17, 2020
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 13, 2019
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
FDA Recall
Terminated
·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020
LoFric Origo, Tiemann, 16in, FR12 urinary catheters
FDA Recall
Terminated
·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
FDA Recall
Terminated
·Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden·Product code EZD·June 17, 2020
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
FDA Recall
Terminated
·Utak Laboratories Inc·Product code JJY·March 20, 2020
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
FDA Recall
Terminated
·XTANT Medical·Product code HWA·May 12, 2020
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code NWV·March 17, 2020
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-lead ECG Waveform files.
FDA Recall
Terminated
·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code MHY·November 19, 2020
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
FDA Recall
Terminated
·Neocis Inc.·Product code PLV·May 14, 2020