BEUDAMED
    FDA Recall Open, Classified

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    Recall: Z-1658-2025 · Initiated October 2, 2023

    Recall

    Recall Number
    Z-1658-2025
    Event Number
    96497
    Firm
    Edge Biologicals Inc
    FEI Number
    1049818
    Product Code
    QMC
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    October 2, 2023
    Posted
    April 23, 2025
    Address
    598 N 2nd St, Memphis, TN, 38105-1634

    Description

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    Reason

    Due to product outer packaging incorrectly labeled.

    Action

    On 10/02/2023, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that Edge Biologicals, Inc. is voluntarily recalling Sterile Water, Catalogue Number T-0780, Lot # 01223 due to the product being mislabeled as T-0627 Sterile Saline 85%. Customers are instructed to located any affected products, stop use and quarantine products until it is able to be returned to Edge Biologics, Inc. Use the following procedures to obtain a Return Merchandise Authorization (RMA): -Send a request per communication to [email protected] titled: RMA requested for 1049818/10022023/R1 -Call 901-523-0034 and request an RMA reference: 1049818/10022023/R1 For Questions, contact Edge Biologicals team members: QC Manager/Microbiologist at [email protected] / Phone 901-523-0034 or FAX 901-527-3343, or Consultant at [email protected] / Phone 858-880-6635

    Distribution

    U.S. Nationwide distribution in the state of PA.

    Quantity

    660 units