The Recall Desk
HighFDA (Devices)·Z-1332-2021·Announced 2021-04-14

Tenacore Alaris Infusion Pump Bezel Recall for Cracking Risk

Tenacore LLC is recalling Alaris Infusion Pump 8100 bezels because they 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/under infusion or interruption), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Tenacore LLC is recalling 1,494 Alaris Infusion Pump 8100 bezels (Part: TIPA-8100-4410). These are plastic repair parts used to service and repair infusion pump modules, not manufactured by the original pump maker. The parts were distributed in the United States to Washington, Arizona, New York, Texas, Louisiana, California, Nevada, Maine, Minnesota, Delaware, North Carolina, Florida, Missouri, Kentucky, Tennessee, and Pennsylvania between July 10, 2020, and January 22, 2021.

The recall is due to a risk that the bezel posts may crack or 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. Specific stock numbers for the affected parts include 271111, 263873, 264442, 264890, 268606, 269930, 270760, 270936, 271211, 272860, 267603, 268936, 269258, 269291, 272496, 272225, 271408, and 267392.

Healthcare facilities and users should stop using these bezels and contact Tenacore LLC for further instructions on the recall.

The recalled product

Product
Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410
Manufacturer
Tenacore LLC
Category
Medical Device — Infusion Pump Parts
Hazard
Affected units
1,494

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)

  • Parts distributed between July 10
  • 2020 and January 22
  • 2021. Time stamp at bezel rear side shows 5 or 6 SO Numbers: 271111
  • 263873
  • 264442
  • 264890
  • 268606
  • 269930
  • 270760
  • 270936
  • 271211
  • 272860
  • 267603
  • 268936
  • 269258
  • 269291
  • 272496
  • 272225
  • 271408
  • 267392

Distribution

Distributed in 16 states:

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

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Same hazard · infusion error

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