Reported Apr 14, 2021 · Terminated
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
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 Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
- Lot codes and dates
Serviced/Repaired between July 102020 and February 182021
- with Serial Numbers
98 of 98 codes
1478990014426738144267039856983403812195866521242165440359104037310404039612653566139799891341061012389912123581781304091612390023125346494038582125336261238998813004789130405649856969404007112437067404843134104681293495912534587404784212436857125336394050744037334129354401253376840401231402083214021684157508391567861814021329136628441366317713662997136631871366287713660363136632142264136629491366303713662922136629881365843613663064136088841366299813663030
- Numbers And No Bezel Ejector Pin Marks
379 of 379 codes
13957538126077001306103813060510130697631305888213061013130584751306121113070091130592531306069313070776130589701306069513060750130607471305862213061106130587661305680813060877126679341332519813495778128762471310795813397686175694591319548812766437141203111411405214117289141240211411808314122300141105171412051214120591130587871305883513070111103866213058798143415051432190514320652143215401432160614321978143220061432158814321576143213121432121813058911130702751305870213405025
- Amount recalled
- 474
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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