25 results
·
69ms
·
Sources: EU EUDAMED, US FDA
FRESH WHOLE BLOOD TRANSFUSION SET
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·June 4, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
FRESH WHOLE BLOOD TRANSFUSION SET
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·January 13, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
VALKYRIE FRESH WHOLE BLOOD SET
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·January 13, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
VALKYRIE FRESH WHOLE BLOOD SET
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·January 13, 2021
VALKYRIE LOW TITER TYPE O WHOLE BLOOD KIT
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·January 13, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COMBAT MEDICAL SYSTEMS LLC·Product code POQ·February 2, 2021
2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·July 27, 2016
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
FDA Recall
Terminated
·Combat Medical Systems, LLC·Product code POQ·December 23, 2020
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
FDA Enforcement
Class I
·Terminated·Combat Medical Systems, LLC·February 24, 2021
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
FDA Enforcement
Class I
·Terminated·Combat Medical Systems, LLC·February 24, 2021
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
FDA Enforcement
Class I
·Terminated·Combat Medical Systems, LLC·February 24, 2021