Recall Z-0372-2014— Hospira Inc.

Name: FDA recall Z-0372-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-28

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-08-28, terminated 2016-11-07. It names one FDA 510(k) clearance: K110901. Product: *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.. Reason: Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-28
Terminated: 2016-11-07
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

*** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery. Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.

Reason for recall

Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.

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