Recall Z-1895-2010
Hospira Inc · initiated April 9, 2010
Product
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.
Codes / lots: All units including List Number Configurations: 16027-04-01/03/04,51/52,53/54, 79/80,81/82,83/84,87/88 and 89/90; 16027-27-89/90; 16027-13-25/26,53/54.
Reason for recall
Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
FDA-determined 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.
Details
- Recall number
- Z-1895-2010
- Initiated
- April 9, 2010
- Posted by FDA
- July 2, 2010
- Terminated
- December 3, 2013
- Product code
- FRN – Pump, Infusion
- Quantity
- 28,485 total
- 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.
- Recalling firm
- Hospira Inc, Morgan Hill, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1894-2010 | Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira…Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect… | 04/09/2010Terminated |