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.
This recall has been terminated (originally issued July 2, 2010).
- Company
- Hospira Inc
- Recall Initiated
- April 9, 2010
- Posted
- July 2, 2010
- Terminated
- December 3, 2013
- Recall Number
- Z-1894-2010
- Quantity
- 28,485 total
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
Distribution
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.
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.
Root Cause
Device Design
Action Taken
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.