The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0185-2024·Announced 2023-11-15

BD Alaris Syringe Module includes non-validated compatible syringes in labeling

CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.

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: "Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated."

Plain-English summary

The BD Alaris Syringe Module (REF 8110), manufactured by CareFusion 303, Inc., is being recalled by the FDA. The product's labeling includes a list of compatible syringes for use with the Alaris Patient Controlled Analgesia infusion pump. Some of these syringes listed as compatible have not been validated for use with the device.

This recall affects 133,727 units distributed worldwide, including throughout the United States and territories, as well as Canada, Germany, Italy, Japan, South Korea, Turkey, Australia, and other countries.

The use of non-validated syringes with the Alaris infusion pump could affect the device's proper functioning. No injuries or illnesses have been reported related to this issue.

Persons who have this device should review the product labeling to ensure only validated syringes are used. Questions about validated syringe compatibility should be directed to CareFusion or the FDA.

The recalled product

Product
BD Alaris Syringe Module, REF 8110
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump / Syringe Module
Hazard
Affected units
133,727

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 (8)

  • All Lots/ UDI-DI:10885403516047
  • 10885403515323
  • 10885403811043
  • 10885403515255 10885403811036
  • 10885403515262
  • 10885403811012
  • 10885403515279
  • 10885403424267

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

Part of a larger recall action

This product is one of 3 recalled by CareFusion 303, Inc. 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 3 products in this recall →

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Same manufacturer · CareFusion 303, Inc.

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