Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
FDA Recall Z-0026-2018 · Posted None
Advertisement
Recalling FirmCareFusion 303, Inc.
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2017-08-09
Product Quantity31,622 units (28,224 in US)
Reason for Recall
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Firm Action
BD sent an Urgent: Medical Device Recall Notification dated September 1, 2017. The customer letter will instruct the customers to remove the pump from service if it shows signs of infusion at an unexpected rate and not to use the affected devices in high risk areas if possible. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering.
Customers will be required to confirm receipt of the notification by
returning the Recall Response Card to BD by postage-paid, self-addressed mail, fax, or email. For further questions, please call (888) 562-6018.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement