Reported Apr 14, 2021 · Terminated
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Tenacore LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tenacore LLC · 1525 E Edinger Ave · Santa Ana, CA · 92705-4907
Is this the product you have?
- Alaris Infusion Pump 8100 Bezel (plastic piece only)
- PartTIPA-8100-4410
- Lot codes and dates
Parts distributed between July 102020 and January 222021. Time stamp at
- bezel rear side shows 5 or 6 SO Numbers
271111263873264442264890268606269930270760270936271211272860267603268936269258269291272496272225271408267392
- Amount recalled
- 1494
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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