Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 53/54, Distributed by: Hospira, Inc. Morgan Hill, CA

FDA Recall Z-0127-2011 · Posted 2010-10-22

Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-02-22
Date Terminated2013-12-03

Reason for Recall

Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.

Firm Action

Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers. Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available. Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.

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.

↑