BEUDAMED
    FDA Recall 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 · Initiated September 22, 2014

    Recall

    Recall Number
    Z-0140-2015
    Event Number
    69373
    Firm
    C P Medical, Inc.
    FEI Number
    3002609049
    Product Code
    NEW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2014
    Posted
    October 27, 2014
    Terminated
    February 17, 2015
    Address
    803 NE 25th Ave, Portland, OR, 97232-2304

    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.

    Action

    CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.

    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