Agency classClass IIOur severity:High FDA (Drugs)·D-0272-2023·Announced 2023-02-22

FDA Recalls 0.9% Sodium Chloride Solution for Lack of Sterility Assurance

Sentara Infusion Services is recalling 114 bags of 0.9% Sodium Chloride intravenous solution due to lack of sterility assurance. The product was distributed nationwide with Beyond Use dates of December 24–31, 2022.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA drug recall for injectable product with lack of sterility assurance. No reported illnesses or injuries stated in the source, but the hazard presents significant infection risk to patients receiving non-sterile injections.

Plain-English summary

Sentara Infusion Services is recalling 0.9% Sodium Chloride intravenous solution due to lack of sterility assurance. The affected product consists of 114 bags distributed in three package sizes (1000 mL, 2000 mL, and 720 mL) with a Beyond Use date of December 24–31, 2022.

The product was dispensed to patients nationwide for use as an intravenous diluent or hydration solution. Lack of sterility assurance in injectable products poses a risk of infection when administered to patients.

Patients who received this product should contact their healthcare provider if they experience symptoms of infection, such as fever, chills, or signs of infection at the injection site. Healthcare providers should review patient records to identify potentially affected patients.

The recalled product

Product: 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
Manufacturer: Sentara Infusion Services
Category: Drug — Intravenous Saline Solution
Hazard: lack-of-sterility
contamination
Affected units: 114

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Beyond Use date December 24 - December 31
2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 53 recalled by Sentara Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 53 products in this recall →

Same manufacturer · Sentara Infusion Services

See all →

High
Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
High
Fluconazole 200mg injection recalled due to sterility concerns
FDA (Drugs) · 2023-02-22
High
Meropenem Injectable Antibiotic Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
High
Cefoxitin injectable bags recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-02-22
High
Vitamin K Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22

Same hazard · lack of sterility