Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in NS, packaged in 1700ML, 1800ML, and 1920ML Homepumps. The recall is due to a lack of assurance of sterility, meaning the product's sterility cannot be guaranteed.
The affected products are prescription-only and were compounded between September 11, 2015, and September 17, 2015. The recall covers one 1700ML bag, seven 1800ML bags, and eight 1920ML bags. These products were distributed in Virginia and North Carolina.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or Sentara Enterprises for further instructions.
The recalled product
- Product
- Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Injectable 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 (4)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15
- b) 30-Sep-15
- c) 28-Sep-15
- 1-Oct-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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