Bridge to Life Ltd has recalled 4,528 units of EasiSlush (0.9% Sodium Chloride Solution for Sterile Slush Preparation) because three production lots did not undergo required quarterly sterilization audits on time. While routine testing for each individual batch was completed properly, the manufacturer missed the scheduled quarterly sampling used to confirm that the gamma sterilization process remains effective at ensuring product sterility. Consumers should stop using the affected lots immediately to prevent potential exposure to non-sterile medical solutions.
The failure to complete timely sterilization audits means the effectiveness of the sterilization process was not validated for these specific lots. Using a solution that may not be fully sterile during medical procedures could lead to severe infections or other serious health complications for patients.
Quantity affected: 4,528 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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