Sentara Recalls Lactated Ringers Due to Sterility Assurance Concerns
Sentara Enterprises is recalling specific lots of Lactated Ringers because product sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria for theoretical risks without reported harm.
Plain-English summary
Sentara Enterprises is recalling Lactated Ringers packaged in 1500ML, 2800ML, and 3600ML Homepumps. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed. The affected product is prescription-only and was compounded between September 11, 2015, and September 17, 2015.
The recall covers specific lots with expirations of September 28, 2015, September 14, 2015, and October 1, 2015. The product was distributed in the United States, specifically in Virginia and North Carolina. The quantities involved are 4 bags of the 1500ML size, 3 bags of the 2800ML size, and 6 bags of the 3600ML size.
Consumers and healthcare providers should stop using the affected product and contact Sentara Home Health Sentara RX at 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176 for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — IV Fluids
- Hazard
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises 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 34 products in this recall →Related recalls
Same manufacturer · Sentara Enterprises
See all →- SevereSentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03
- HighSentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Tobramycin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
FDA (Drugs) · 2016-02-03
- SevereSentara Recalls Gentamicin Homepumps Due to Sterility Concerns
FDA (Drugs) · 2016-02-03
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighLactated Ringers IV Solution Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-02-22
- SevereSCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns
FDA (Drugs) · 2017-11-08
- SevereHospira Recalls Lactated Ringer's Injection Due to Sterility Concerns
FDA (Drugs) · 2014-12-03
- HighLevothyroxine Injectable Syringes Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighKYTRIL Antiemetic Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-22
- HighOxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31