0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c)...
FDA Recall #D-0272-2023 — Class II — December 27, 2022
Product Description
0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Reason for Recall
Lack of sterility assurance
Recalling Firm
Sentara Infusion Services — Chesapeake, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
114 bags total
Distribution
Dispensed to Patients Nationwide.
Code Information
Beyond Use date December 24 - December 31, 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated