CareFusion Recalls Pyxis Anesthesia System Model 2000 Due to Drawer Inaccessibility
CareFusion is recalling 2,637 Pyxis Anesthesia System Model 2000 units because system downtime or lock-ups can make medication drawers inaccessible.
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: The recall involves a medical device where a functional failure (drawer inaccessibility) poses a risk of harm by preventing access to critical medications, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
CareFusion Corporation is recalling the Pyxis Anesthesia System Model 2000 (PAS 2000). This device is used in operating rooms to dispense anesthesia medications and manage inventory for anesthesiologists.
The recall was initiated because CareFusion confirmed that the PAS 2000 drawers can become inaccessible due to system downtime or lock-ups. This issue may prevent healthcare providers from accessing necessary medications at the point of care.
A total of 2,637 units were distributed worldwide, including the United States and Canada. Healthcare facilities should contact CareFusion for instructions on how to address the issue.
The recalled product
- Product
- Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
- Manufacturer
- CareFusion Corporation
- Affected units
- 2,637
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 (1)
- All Pyxis Anesthesia System Model 2000
Distribution
Distributed nationwide across the United States.
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