Sentara Recalls Dextrose-5% Lactated Ringers Due to Sterility Concerns
Sentara Enterprises is recalling 7 bags of Dextrose-5% Lactated Ringers because the sterility of the product cannot be guaranteed.
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 involves a risk-of-harm product (sterility issue) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Sentara Enterprises is recalling 7 bags of Dextrose-5% Lactated Ringers packaged in 3000ML Homepumps. The product is prescription-only and was distributed in Virginia and North Carolina. The recall affects all lots compounded between September 11, 2015, and September 17, 2015, with an expiration date of September 28, 2015.
The recall was initiated because the sterility of the product cannot be guaranteed. This lack of assurance of sterility presents a potential risk to patients using the intravenous solution.
Consumers and healthcare providers should stop using the affected product immediately. Patients should contact their healthcare provider for further instructions or alternative treatment options.
The recalled product
- Product
- Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 7
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 (1)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-15
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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