Recall Z-0814-2016— CareFusion 303, Inc.
Class II · Terminated
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-01-15, terminated 2017-05-08. FDA's recall record names no specific 510(k) clearance for this event. 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 system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.. 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
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-15
- Terminated
- 2017-05-08
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.