Company: Hospira, Inc.
Date of Enforcement Report 11/3/2016
Class lI:
PRODUCT
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Recall Number Z-0305-2017
REASON
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the “NEXT” button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury..
RECALLING FIRM/MANUFACTURER
Hospair, Inc., Lake Forest, IL on 10/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
35,596 devices
DISTRIBUTION
Nationwide and Canada
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