Z-2671-2017 Class II Terminated
FDA device recall Z-2671-2017 was initiated by CareFusion 303, Inc. on June 12, 2017 and is designated Class II. Reason for recall: BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrup… The recall status is terminated (terminated October 26, 2018). Affected quantity: 568,283 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- June 12, 2017
- Termination Date
- October 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 568,283 units
Product Description
Alaris PC Unit, Model 8015
Reason for Recall
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Code Information
Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.