BEUDAMED
    FDA Recall Open, Classified

    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

    Recall: Z-2157-2025 · Initiated June 12, 2025

    Recall

    Recall Number
    Z-2157-2025
    Event Number
    97143
    Firm
    Bridge to Life Ltd
    FEI Number
    3015942785
    Product Code
    KDN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 12, 2025
    Posted
    July 22, 2025
    Address
    707 Skokie Blvd, Ste 340, Northbrook, IL, 60062-2838

    Description

    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

    Reason

    The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

    Action

    Bridge to Life issued an IMPORTANT FIELD SAFETY NOTICE to its consignees on 06/12/2025 via email. The notice explained the issue and requested the following: Actions required by the customer: 1. To be aware and acknowledge this field safety notice. 2. We are requesting customers to conduct a review of the existing EasiSlush inventory to determine if you have any quantities of the following three lot numbers 240372708, 240372836, 240402837. 3. If you may have further distributed the product, we request that quantity be included in your review and please advise us on where your product is forwarded with contact information. 4. Immediately notify Bridge to Life of the quantities in inventory. Fill out FSN Customer Reply Form below and send it back to the email address [email protected] 5. FSN Customer Reply Form must be returned no later than June 18, 2025. 6. Lastly, please confirm no adverse events related to the subject lots and advise if you have any additional questions or concerns. For questions, please contact [email protected] or 800-667-9524.

    Distribution

    United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada

    Quantity

    4528 units