Recall Z-0354-2017— Hospira Inc.

Name: FDA recall Z-0354-2017
Creator: U.S. Food and Drug Administration
Published: 2013-02-05

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-02-05, terminated 2016-12-15. It names one FDA 510(k) clearance: K110901. Product: Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027. Reason: Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-05
Terminated: 2016-12-15
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110901 — SYMBIQ INFUSION AND ADMINSTRATION SETHospira, Inc.·cleared 2012-03-05

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

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027

Reason for recall

Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.

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