—#92057

Product

Hospira brand Symbiq One-Channel Infuser; List Number: 16026; 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 product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550
Affected lot / code info: All units including List Number Configurations: 16026-04-01/03/04,51/52,53/54, 79/80,81/82,83/84,87/88 and 89/90; 16026-27-89/90; 16026-13-25/26, 53/54.

Why it was recalled

Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

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.

Timeline

Recall initiated: 2010-04-09
Posted by FDA: 2010-07-02
Terminated: 2013-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92057. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.