Tenacore Recalls Alaris Infusion Pump Modules with Impacted Bezel Repair Parts
Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, potentially causing infusion errors.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
Tenacore LLC is recalling 474 Alaris Infusion Pump Modules, Model 8100, that were serviced or repaired between July 10, 2020, and February 18, 2021. These units were distributed to facilities in Washington, Arizona, New York, Texas, Louisiana, California, Nevada, Maine, Minnesota, Delaware, North Carolina, Florida, Missouri, Kentucky, Tennessee, and Pennsylvania.
The recall is due to bezel repair parts used by Tenacore that were not manufactured by the original equipment manufacturer. Over time, these parts may experience cracking or separation of the posts from the bezel. If one or more posts separate, it may result in free flow, over-infusion, under-infusion, or interruption of the infusion.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Affected units should be removed from service and returned to Tenacore LLC for inspection and repair.
The recalled product
- Product
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part
- Manufacturer
- Tenacore LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 474
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serviced/Repaired between July 10
- 2020 and February 18
- 2021 with Serial Numbers: 14789900
- 14426738
- 14426703
- 9856983
- 4038121
- 9586652
- 12421654
- 4035910
- 4037310
- 4040396
- 12653566
- 13979989
- 13410610
- 12389912
- 12358178
- 13040916
- 12390023
- 12534649
Distribution
Part of a larger recall action
This product is one of 2 recalled by Tenacore LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Tenacore LLC
See all →- SevereTenacore Alaris Infusion Pump Bezel Recall for Cracking Risk
FDA (Devices) · 2021-04-14
Same hazard · infusion error
See all →- SevereIvenix Infusion System software recalled for pump malfunction risk
FDA (Devices) · 2025-02-12
- SevereStep-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts
FDA (Devices) · 2021-05-19
- SevereInfusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
FDA (Devices) · 2021-05-19
- SevereAftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
FDA (Devices) · 2021-04-28
- SevereCareFusion Recalls BD Alaris Modules for Incorrect Syringe Display
FDA (Devices) · 2020-09-16
Similar recalls
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- SevereInfusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
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- CriticalAlaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
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- SevereStep-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts
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- SevereAftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
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