Nurse Assist, LLC is recalling 0.9% sodium chloride irrigation USP and sterile water for irrigation USP citing the potential for a lack of sterility assurance, the U.S. Food and Drug Administration said.<\/p>\n
The product could be nonsterile, and there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events in populations most at risk, such as patients who are immunocompromised.<\/p>\n
However, the company has not received any reports of adverse events for these products to date.<\/p>\n
The recalled 0.9% Sodium Chloride Irrigation USP comes with 100 mL bottles, 250 mL 500 mL and 1000mL bottles, as well as 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes.<\/p>\n
Sterile Water for Irrigation USP was available in 100 mL, 250 mL, 500 mL and 1000mL bottles, as well as 120 mL cups, 10mL syringes, and 30mL syringes.<\/p>\n
The products’ expiration dates range from November 1, 2023 to September 18, 2025 for all part numbers. This excludes part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N), which has an expiration date range from November 1, 2023 to September 18, 2028.<\/p>\n
The products were distributed in the United States and Canada from November 1, 2021 to September 18, 2023.<\/p>\n
The recalled products may be repackaged into medical device convenience kits.<\/p>\n
The recall was initiated after the potential for a compromised sterile barrier was identified during routine product testing.<\/p>\n
Consumers who have the impacted products are urged to stop using them and contact their distributor or Nurse Assist for return authorization.<\/p>\n
In similar recalls, Cardinal Health, Inc. last week recalled certain Leader branded eye drops supplied by Velocity Pharma, LLC citing potential risk of eye infections due to insanitary conditions in the manufacturing facility.<\/p>\n
Phoenix, Arizona-based Pharmedica USA LLC in Match recalled Purely Soothing, 15 percent MSM eye drops to the consumer level due to non-sterility.<\/p>\n
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