Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
FDA Recall Z-1895-2010 · Posted 2010-07-02
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Recalling FirmHospira Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-04-09
Date Terminated2013-12-03
Product Quantity28,485 total
Reason for Recall
Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
Firm Action
Hospira issued a "Urgent: Medical Device Recall Notification" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form.
For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and United Arab Emirates.
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.
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