The Recall Desk
SevereFDA (Devices)·Z-0184-2024·Announced 2023-11-15

Alaris PCA Module 8120 infusion pump recalled for unvalidated syringes

CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated. This Class I recall affects 867,362 units worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall, the most serious category for medical devices. The labeling lists compatible syringes that have not been validated for use with the pump, which could result in medication delivery problems if unsuitable syringes are used. No injuries or deaths have been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris PCA Module 8120 patient-controlled analgesia infusion pump due to an issue with the device labeling. Specifically, the labeling lists compatible syringes that have not been validated for use with this pump.

The FDA has classified this as a Class I recall, which is the agency's most serious classification for device problems. A total of 867,362 units were distributed worldwide, including throughout the United States and to multiple countries such as Canada, Germany, Japan, and Australia.

Users who have this pump should verify that only validated syringes are used with their device. Affected customers should contact CareFusion 303, Inc. for accurate information regarding which syringes are appropriate for use with this pump.

The recalled product

Product
BD Alaris PCU REF 8015
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Drug Infusion Pump
Hazard
Affected units
867,362

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 (9)

  • All Lots/ UDI DI: 10885403516030
  • 10885403515316
  • 10885403812033
  • 10885403515286
  • 10885403812026
  • 10885403515293
  • 10885403494291
  • 10885403515309
  • 10885403812002

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 →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · labeling error

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