FDA Device

Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient use Rx device; Hospira Inc, Lake Forest, IL USA. made in Costa Rice; product number 160000401, list number 16000-01.

Hazard

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

What You Should Do

Remedy

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.

Products

Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient u
Brand
Hospira Inc.
UPC
Lot numbers: 481915H, 491795H, 510525H, 520525H, 591615H, 801155H, 810745H, and 820715H.

Units Affected

45,537 sets