Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the rubric identifies as Critical severity. Bezel separation poses serious potential for patient harm via free flow, over-infusion, under-infusion, or treatment interruption in infusion therapy.
Plain-English summary
The FDA is recalling 22 Alaris Infusion Pump Module Model 8100 units that were serviced and repaired with a non-manufacturer bezel repair part (TIPA-8100-4410 / Alaris 8100 Bezel) by The Biomed Guys. The affected units were distributed to Indiana and Texas and were serviced between September 2020 and February 2021.
The bezel repair part may experience cracking and/or separation of the bezel posts. If one or more bezel posts separate, the pump could malfunction, resulting in free flow (uncontrolled medication delivery), over-infusion (excessive medication), under-infusion (insufficient medication), or interruption of infusion (therapy stoppage).
Consumers and healthcare facilities with affected units should verify the device serial numbers: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, and 12796415.
The recalled product
- Product
- Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
- Manufacturer
- The Biomed Guys
- Category
- Medical Device — Infusion Pump
- Affected units
- 22
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)
- Serial numbers of serviced devices
- serviced 09/2020-02-2021: 12833065
- 13187021
- 13187811
- 12838069
- 12982509
- 12837231
- 12835186
- 12837972
- 12710593
- 12776790
- 13753893
- 13605919
- 12832544
- 15763526
- 14806203
- 14806612
- 14807070
- 13738432
- 15763547
Distribution
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