Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES

FDA device recall Z-0814-2016 · posted 2016-02-16 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

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.

Action taken

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 instructed to contact CareFusion Technical Support at (800) 727-6102.

Root cause

Device Design

Status

Terminated

Product code

BRY

Quantity affected

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.

Date initiated

2016-01-15

Date posted

2016-02-16

Date terminated

2017-05-08

Location

San Diego, CA