Recall Z-0814-2016 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
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.
| Date | Feb 16, 2016 (initiated Jan 15, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | BD sent an Urgent Medical Device Recall Notification letter dated January 15, 2015 to all affected customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete the enclosed Customer Response Card by selecting the desired deployment option and return the card to CareFusion. Customers with questions are instructed to contact the CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact CareFusion Customer Advocacy at (800) 836-7842. Customers with technical questions are instruct |
| Quantity | 9,345 units |
| Distribution | Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.