BEUDAMED
    FDA Recall Terminated

    RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization

    Recall: Z-0771-2017 · Initiated November 22, 2016

    Recall

    Recall Number
    Z-0771-2017
    Event Number
    75781
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 22, 2016
    Terminated
    November 24, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization

    Reason

    Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers with affected stock, immediately discontinue use and quarantine any affected products. To return product, customers were advised to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Customers with no affected stock should also complete the enclosed Recall Acknowledgment Form to confirm receipt of the letter. Customers with questions should contact Customer Service at 1-866-246-6990.

    Distribution

    Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.

    Quantity

    102,843 units