BEUDAMED
    FDA Enforcement Class II Terminated

    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

    Recall: Z-0140-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0140-2015
    Event ID
    69373
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C P Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 5, 2014
    Initiation Date
    September 22, 2014
    Classification Date
    October 27, 2014
    Termination Date
    February 17, 2015
    Address
    803 NE 25th Ave, N/A, Portland, OR, 97232-2304, United States

    Description

    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.

    Reason

    CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.

    Code Info

    Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.

    Distribution

    US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA

    Quantity

    74 boxes /12 sutures per box; plus an additional 13 sutures