Company: CareFusion 303, Inc.
Date of Enforcement Report 2/24/2016
Class lI:
PRODUCT
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. Recall Number Z-0814-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego CA on 1/15/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9,345 units
DISTRIBUTION
US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
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