Lactated Ringers IV Solution Recalled for Sterility Assurance Failure
Sentara Infusion Services is recalling Lactated Ringers IV solutions (NDC 00338-0117-03) due to lack of sterility assurance. The recall affects 25 bags dispensed nationwide with a Beyond Use Date 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: This is an FDA Class II recall of an intravenous medication due to lack of sterility assurance. While no illnesses or injuries have been reported, the hazard involves a theoretical risk of contamination in an injectable product used for patient care, which qualifies as a risk-of-harm scenario without reported injury.
Plain-English summary
Sentara Infusion Services is recalling Lactated Ringers intravenous solutions packaged in volumes of 500ML, 1000ML, 2500ML, 3000ML, and 3600ML with NDC 00338-0117-03. A total of 25 bags were distributed nationwide to patients through Sentara Home Infusion Pharmacy Services.
The recall has been issued due to lack of sterility assurance. Lactated Ringers is used for hydration and is administered via Curlin pump. Sterility is a critical requirement for intravenous medications.
The affected product has a Beyond Use Date of December 24-31, 2022. For additional information about this recall, contact Sentara Infusion Services at 535 Independence Pkwy, Suite 300, Chesapeake, VA 23320.
The recalled product
- Product
- 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
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Intravenous Solution
- Affected units
- 25
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 24-31
- 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.
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