FDA-Device2016-02-24Class II

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 system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

CareFusion 303, Inc.
Hazard

Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.

Sold states
Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
Affected count
9,345 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
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 system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0814-2016

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