Device Recall 0.9 Sodium Chloride Flush Syringe

  • Modèle / numéro de série
    List Number 1078-20, lots 91-100-5E, 91-102-5E, 91-106-5E, 91-114-5E, 91-116-5E and 91-118-5E.  The recall was expanded to include the following additional lot numbers: 92-131-5E, 92-133-5E, 93-211-5E, 93-229-5E, 93-230-5E, 93-232-5E, 94-224-5E, 94-230-5E, 94-233-5E, 95-182-5E, 01-168-5E, 01-170-5E and 02-157-5E.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution including states of: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.
  • Description du dispositif
    0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list no. 1978-20 || lock flush solution
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
  • Source
    USFDA