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.
What this means for you
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
- Hazard
- lack-of-sterility
- contamination
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.
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