BEUDAMED
    FDA Recall Open, Classified

    Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;

    Recall: Z-0934-2023 · Initiated December 15, 2022

    Recall

    Recall Number
    Z-0934-2023
    Event Number
    91350
    Firm
    Stradis Healthcare
    FEI Number
    1450943
    Product Code
    PXC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 15, 2022
    Posted
    January 11, 2023
    Address
    3600 Burwood Dr, Waukegan, IL, 60085-8399

    Description

    Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;

    Reason

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

    Action

    Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.

    Distribution

    US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

    Quantity

    21,755 units