Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03...

FDA Recall #D-0300-2023 — Class II — December 27, 2022

Recall #D-0300-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, 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

25 bags

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 24-31, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated