21 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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CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
FDA Enforcement
Class II
·Terminated·CAREstream Medical LLC·August 29, 2018
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f. CMI-0100-PNX-NHS-PS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System with Passive Scavenger; g. CMI-0100-PNX-US, Pro-Nox mixer, 6' high-pressure O2 and N2O hoses
FDA Recall
Terminated
·CAREstream Medical LLC·Product code BZR·May 15, 2018
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.
FDA Recall
Terminated
·Life Technologies, Corp.·Product code NDS·May 10, 2018
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·June 12, 2013
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KHS·June 12, 2013
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.
FDA Recall
Terminated
·Life Technologies, Corp.·Product code NDS·May 10, 2018
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·April 1, 2020
GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.
FDA Recall
Terminated
·Life Technologies, Corp.·Product code NDS·May 10, 2018
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
FDA Recall
Terminated
·Life Technologies, Corp.·Product code NDS·May 10, 2018
StemPro MSC SFM CTS"
FDA Recall
Terminated
·Life Technologies Corporation·Product code NDS·June 11, 2019
Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.
FDA Recall
Terminated
·Life Technologies, Corp.·Product code NDS·May 10, 2018
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·June 12, 2013
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·April 1, 2020
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Recall
Terminated
·Abbott GmBH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code KHS·October 23, 2019