FDAMarch 25, 2021device
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
What to do
FDA enforcement status: Ongoing
Brands named
biomed guysbiomed
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCThe Lye Guy Recalls Sodium and Potassium Hydroxide Products Due to Failure to Meet Child Resistant Packaging Requirement and Violation of FHSA Labeling (Recall Alert)2021-05-13
- CPSCBioMed Balance Recalls Wintergreen and Sweet Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning2020-07-22
- FDAZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 036635370468102018-02-05
- FDAZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.2018-02-05
- FDAZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.2018-02-05
- FDAJoe Chips Retro Potato Chips Sour Cream & Toasted Onion Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-7502 Net Wt. 2 OZ UPC 743234001725 Net Wt. 5 OZ UPC 7432340018002016-12-28
- FDAZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.2011-11-09
- FDAZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.2011-11-09
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →