Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 d
FDA device recall Z-1054-2010 · posted 2010-03-09 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Action taken
- Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2,016 sets
- Distribution
- Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
- Date initiated
- 2009-11-24
- Date posted
- 2010-03-09
- Date terminated
- 2012-01-29
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |