The solutions of 0.9% sodium chloride irrigation (saline) and sterile water for irrigation are being pulled because of a “lack of sterility assurance,” the FDA said Nov. 6. The drugs are used for flushing wounds and medical tubing, such as intravenous catheters and urinary catheters.
Products were distributed individually and in “medical device convenience kits,” and solutions include bottles, spray cans and prefilled syringes, the FDA said. Nurse Assist has not received any adverse event reports related to the issue, which could be severe or life-threatening to immunocompromised people.
“The potential for a compromised sterile barrier was identified during routine product testing. Further investigations prompted a widening of product scope out of an abundance of caution,” the regulatory agency said. “Consumers who have these products should stop using them and contact their distributor or Nurse Assist for return authorization.”
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