The affected products contain 0.9% sodium chloride irrigation USP from Nurse Assist, which recalled more than 70 solutions of saline and sterile water products in early November due to the potential for a lack of sterility assurance.
Medline is asking healthcare organizations to report the number of affected products in their inventory. In response, the company will send organizations warning labels for affected kits and trays that instruct clinicians to remove and discard the recalled saline products.
To date, there have been no reports of patient harm tied to the recalled products in the kits and trays, the FDA said.
Medline issued a Class I recall for the product, though the FDA clarified it as a warning and not a product removal.
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