5 results
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45ms
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Sources: EU EUDAMED, US FDA
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 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·Tenacore LLC·April 14, 2021
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·December 7, 2016
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