Class 2 Device Recall MonoDox Synthetic Absorbable Suture, Sterile

• Date Initiated by Firm: September 17, 2008
• Date Posted: September 27, 2010
• Recall Status: Terminated on September 28, 2010
• Recall Number: Z-2582-2010
• Recall Event ID: 49599
• 510(K)Number: K013274
• Product Classification: Absorbable Polydioxanone Surgical Suture - Product Code NEW
• Product: 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.
• Code Information: Lot number L0535440, EXP 2009-11.
• FEI Number: 3002609049
• Recalling Firm/ Manufacturer: C P Medical; 803 Ne 25th Ave; Portland OR 97232-2304
• For Additional Information Contact: Customer Service Representative; 800-950-2763
• Manufacturer Reason for Recall: Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.
• FDA Determined Cause: Vendor change control
• 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.
• Quantity in Commerce: 1684/12 pcs. Boxes (1628/12 pcs. Boxes to veterinary market, 56/12 pcs. Boxes to human suture market)
• Distribution: Worldwide Distribution -- US, Australia, and Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NEW