Recall Z-0626-2013— Hospira Inc.

Name: FDA recall Z-0626-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-07

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2012-12-07, terminated 2016-11-14. It names one FDA 510(k) clearance: K081412. Product: Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.. Reason: The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-07
Terminated: 2016-11-14
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K081412 — PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.·cleared 2008-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.

Reason for recall

The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.

Data sourced from openFDA. This site is unofficial and independent of the FDA.