411 results
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17ms
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Sources: EU EUDAMED, US FDA
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018
BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code FOZ·May 10, 2018
Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·May 10, 2018
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease.
FDA Recall
Terminated
·Diamedix Corporation·Product code MST·March 21, 2008
CRITIFLO(tm) FLUSH KIT
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
CRITIFLO(tm) flush kit.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
TAKHPQ60R continuous flow catheter.
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
DTX(tm) Plus DT-DL60 Continuous flush catheter
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
DT-DL60-1 W/Bifurcated
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
CRITIFLOW(tm) TA4004 continuous flush catheter
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
CRITIFLO(tm) TAK0460 continuous flow catheter
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code KRA·July 1, 2005
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJS·November 28, 2016
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013