CareFusion Recalls Jadak Barcode Scanners for Pyxis Anesthesia Systems
CareFusion 303, Inc. is recalling 9,345 Jadak Barcode Scanners used with Pyxis Anesthesia systems because they may transmit incorrect medication information to the dispensing system.
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 used for medication dispensing where a defect could lead to the administration of the wrong medication. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
CareFusion 303, Inc. is recalling 9,345 units of the Jadak Barcode Scanner (Part No. 350587-32, 350587-41, 351377-32). These scanners are accessories used with the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations to scan medication labels during refills and dispensing.
The recall was initiated because customers reported issues when scanning medications. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product. This potential for data mismatch could lead to the dispensing of the wrong medication.
The affected units were distributed nationwide in the United States and in Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam, and the Bahamas. Healthcare facilities using these specific scanner part numbers with Pyxis Anesthesia systems should verify their inventory against the provided list of serial numbers and contact CareFusion 303, Inc. for further instructions.
The recalled product
- Product
- Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES…
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 9,345
Distribution
Distributed nationwide across the United States.
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