Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management
Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device with risk of network connectivity loss affecting infusion pump data management. The source reports no illnesses or injuries, and the hazard is potential rather than realized, placing this at Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
CareFusion 303, Inc. is recalling certain Alaris PC Unit 8015 infusion pump computers. The affected units use specific wireless network cards (802.11 b/g or 802.11 a/b/g) configured with IP addresses in a particular range. Approximately 83,185 units have been distributed in the United States and internationally.
These devices may experience wireless network connectivity failure. When connectivity is lost, the PC unit cannot receive new datasets or transfer analytics data to connected systems. For systems integrated with electronic medication records, users may be unable to receive or transmit necessary data.
If network connectivity fails, infusions may need to be manually programmed instead of remotely configured. This affects healthcare facilities and providers using these systems for infusion pump management. No illnesses or injuries have been reported.
The recalled product
- Product
- Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device
- Affected units
- 83,185
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 PC Units
- UDI-DI: 10885403801549
- 10885403801532
- with software versions 12.1.0
- 12.1.2
- 12.1.3
- utilizing affected network cards and IP addresses
Distribution
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