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.
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: 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.
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