Sentara Recalls Sodium Chloride Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Sodium Chloride Homepumps because the sterility of the product cannot be guaranteed.
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 involves a high-risk pathogen risk (lack of sterility assurance) for an intravenous product, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentara Enterprises is recalling specific lots of Sodium Chloride (SOD CHLORIDE) packaged in Homepumps. The affected products include various concentrations (0.9% and 0.45%) and volumes (30ml, 218ml, 500ml, 1500ml, and 1920ml). These products were compounded between September 11, 2015, and September 17, 2015, and are distributed in Virginia and North Carolina.
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.
Patients and healthcare providers should stop using the affected lots immediately. Consumers should check their medication labels for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.3
- Manufacturer
- Sentara Enterprises
- Category
- Drug — IV Solution
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 (6)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15
- 1-Oct-15
- b) 22-Sep-15
- c) 30-Sep-15 d) 29-Sep-15
- e) 25-Sep-15
- f) 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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