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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that can lead to infusion errors (over-infusion, under-infusion, or interruption), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
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 →- HighTenacore 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
- HighInfusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
FDA (Devices) · 2021-05-19
- HighStep-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts
FDA (Devices) · 2021-05-19
- HighAftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
FDA (Devices) · 2021-04-28
- HighCareFusion Recalls BD Alaris Modules for Incorrect Syringe Display
FDA (Devices) · 2020-09-16