Alaris PCA Module 8120 Infusion Pump Syringes Labeling Contains Unvalidated Products
CareFusion is recalling the Alaris PCA Module 8120 infusion pump because its labeling lists compatible syringes that have not been validated for use with the device.
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: This is an FDA Class I medical device recall, which mandates a minimum severity score of 4. The labeling error creates risk of using unvalidated syringes with a critical infusion pump, potentially leading to medication administration errors.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris PCA Module 8120, a patient-controlled analgesia infusion pump used to deliver pain medication. The device labeling lists compatible syringe models, but some of these syringes have not been validated for use with the pump.
Use of unvalidated syringes with this infusion pump could result in medication administration errors. This is an FDA Class I recall.
Approximately 86,393 units have been distributed worldwide, including throughout the United States and internationally. The recall affects all lots of the Alaris PCA Module 8120.
Users should contact CareFusion 303, Inc. for information about validated syringe options and further guidance on this recall.
The recalled product
- Product
- Alaris PCA Module 8120
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 86,393
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 (7)
- All Lots/ UDI-DI: 10885403516023
- 10885403515231
- 10885403801549
- 10885403515248
- 10885403801532
- 10885403515224
- 10885403801518
Distribution
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.
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