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.
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: 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.
- 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
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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