PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: February 22, 2023 Initiated: December 27, 2022 #D-0300-2023

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

Details

Recalling Firm
Sentara Infusion Services
Units Affected
25 bags
Distribution
Dispensed to Patients Nationwide.
Location
Chesapeake, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Sentara Infusion Services. Units affected: 25 bags.
Why was this product recalled?
Lack of sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0300-2023.