Agency classClass IOur severity:Severe FDA (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.

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 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: infusion-error
mechanical-failure
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 →

Same manufacturer · Tenacore LLC

See all →

Severe
Tenacore Recalls Alaris Infusion Pump Modules with Impacted Bezel Repair Parts
FDA (Devices) · 2021-04-14

Same hazard · infusion error