The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2882-2020·Announced 2020-09-16

CareFusion Recalls BD Alaris Modules for Incorrect Syringe Display

CareFusion 303, Inc. is recalling BD Alaris Syringe and PCA Modules because they may display incorrect syringe types or sizes, 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: "The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion."

Plain-English summary

CareFusion 303, Inc. is recalling specific BD Alaris System components, including the Alaris Syringe Module Model 8110, Alaris PCA Module Model 8120, and the Syringe/PCA Sizer Sensor Replacement Kit (P/N 122278652). The recall involves 180,186 parts and devices distributed across the United States and several international locations.

The recall was initiated because the Alaris PC unit can display incorrect syringe types and/or syringe sizes. This defect could result in delays in infusion, under-infusion, or over-infusion of medication. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and users should stop using the affected devices and contact CareFusion 303, Inc. for further instructions. The affected serial numbers for the PCA Module Model 8120 are extensive and listed in the official recall documentation.

The recalled product

Product
BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pumps
Hazard
Affected units
180,186

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 (2)

  • Device Model/Serial Number: Syringe/PCA Sizer Sensor Replacement Kit
  • P/N 122278652: All Kits

Distribution

Distributed in 54 states:

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