Alcon Research, LLC is recalling approximately 886 Medline Bulb irrigation syringes (2oz/60cc, Green) that were packaged inside various Alcon Custom-Pak Surgical Procedure Packs. The recall was issued because the sterile barrier of the individual syringe packaging may have been breached before being placed into the surgical packs. While the entire procedure pack is sterilized, once the pack is opened, these syringes cannot be guaranteed sterile for subsequent use and should be discarded after a single surgical case. Using a non-sterile syringe during surgery can lead to serious patient infections.
The sterile barrier of the syringe may be compromised, meaning the device could be contaminated with bacteria or other pathogens. If a non-sterile syringe is used for irrigation during a medical procedure, it significantly increases the risk of the patient developing a healthcare-associated infection.
You have 2 options:
Discard affected syringes after surgical case end.
Medical device guidance and support.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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