7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
FDA Enforcement
Class I
·Ongoing·Infusion Pump Repair·May 19, 2021
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
FDA Enforcement
Class I
·Ongoing·The Biomed Guys·June 9, 2021
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·Tenacore LLC·April 14, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·Tenacore LLC·April 14, 2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Enforcement
Class I
·Ongoing·Pacific Medical Group Inc.·April 28, 2021