—#87449

Product

Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 161010728, REF16101

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550
Affected lot / code info: Lot numbers: 782305H and 801365H.

Why it was recalled

Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 375 N Field Dr, Lake Forest, Illinois 60045-2513

Distribution

Distribution pattern: Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.

Timeline

Recall initiated: 2009-11-24
Posted by FDA: 2010-03-09
Terminated: 2012-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87449. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.