Infusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
Infusion Pump Repair is recalling 15 Alaris Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, 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/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
Infusion Pump Repair is recalling 15 Alaris Pump Modules, Model 8100, that were serviced or repaired using bezel repair parts not made by the original manufacturer. These devices were distributed in California between January 15, 2021, and March 14, 2021.
The recall is due to a risk that the non-original bezel repair parts may crack or have their posts separate from the bezel over time. If this separation occurs, it may result in free flow, over-infusion, under-infusion, or interruption of the infusion.
Healthcare facilities and users who have these specific devices should stop using them and contact Infusion Pump Repair for further instructions. The recall covers specific serial numbers and sale order numbers listed in the agency's official documentation.
The recalled product
- Product
- Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
- Manufacturer
- Infusion Pump Repair
- Category
- Medical Device — Infusion Pumps
- Affected units
- 15
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 (14)
- 13617863
- 13447266
- 13089105
- 12333728
- 13616451
- 13618575
- 12729374
- 82943/ 4122252
- 4122320
- 01112101A/ 12638236
- 13813590
- 12639090
- 13744738
- 9951014
Distribution
Distributed in 1 state:
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