BEUDAMED
    FDA Recall Terminated

    Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

    Recall: Z-2582-2010 · Initiated September 17, 2008

    Recall

    Recall Number
    Z-2582-2010
    Event Number
    49599
    Firm
    C P Medical
    FEI Number
    3002609049
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    September 17, 2008
    Posted
    September 27, 2010
    Terminated
    September 28, 2010
    Address
    803 Ne 25th Ave, Portland, OR, 97232-2304

    Description

    Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.

    Reason

    Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.

    Action

    On 09/17/2008, the firm's Sale Representative began using the Telephone Script and calling all their customers. On 09/19/2008, the firm began sending the Recall Notice, dated 9/17/2008, letter to their customers. The letter states that the recalled product is Polydioxanone Suture, Code M397, Lot Number L0535440, Expiration Date: November 2009. The customers are advised to discontinue selling this product and return any existing stock to CP Medical. The firm also requests their consignees to notify their sub-accounts about this recall notice if the product is further distributed. The customers are instructed to provide return all accounted quantity and provide quantify information and location of any product that they are unable to recover for accountability purposes. Customers could contact CP Medical Customer Service Representative at 1-800-950-2763 for return goods authorization number and shipping account number.

    Distribution

    Worldwide Distribution -- US, Australia, and Taiwan.

    Quantity

    1684/12 pcs. Boxes (1628/12 pcs. Boxes to veterinary market, 56/12 pcs. Boxes to human suture market)