Sodium Chloride Diluent Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Sodium Chloride 0.9% solution dispensed to patients nationwide due to lack of sterility assurance. The product was used as a diluent in home infusion therapy with Curlin or Sapphire pumps.
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: FDA Class II recall of a sterile injectable product with confirmed loss of sterility assurance. No reported illnesses or injuries have been documented, but the product poses a direct risk of harm to patients who received intravenous infusions, meeting the rubric criterion for High severity.
Plain-English summary
Sentara Infusion Services is recalling Sodium Chloride 0.9% solution in sizes of 100 mL, 69.3 mL, 71.4 mL, 77.7 mL, 130 mL, 190 mL, 210 mL, and 220 mL. The product is used as a diluent with Curlin or Sapphire infusion pumps for home infusion therapy.
The recall is due to lack of sterility assurance. Sterile injectable products used directly in patient infusions must meet strict sterility standards. This product does not have adequate assurance of maintaining required sterility.
The product was dispensed to patients nationwide. Eleven bags were distributed with a Beyond Use Date of December 24–30, 2022.
Patients who received this product should contact their healthcare provider or Sentara Infusion Services immediately. Do not use the product if you have it. Seek medical attention if you have received an infusion from this product lot and experience any unusual symptoms.
The recalled product
- Product
- Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Diluent
- Hazard
- sterility-failure
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 (2)
- Beyond Use Date: December 24- 30
- 2022
Distribution
Distributed nationwide across the United States.
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