BEUDAMED
    FDA Enforcement Class II Terminated

    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. 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 (2.0 metric), PS-1 Needle

    Recall: Z-1708-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1708-2014
    Event ID
    68153
    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
    June 11, 2014
    Initiation Date
    April 23, 2014
    Classification Date
    June 3, 2014
    Termination Date
    September 12, 2014
    Address
    803 NE 25th Avenue, Portland, OR, 97232-2304, United States

    Description

    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. 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 (2.0 metric), PS-1 Needle

    Reason

    CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

    Code Info

    Lot 130826-08, expiration 2015-07.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).