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U.S. Department of Health and Human Services

Class 2 Device Recall MonoDox Synthetic Absorbable Suture, Sterile

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  Class 2 Device Recall MonoDox Synthetic Absorbable Suture, Sterile see related information
Date Initiated by Firm September 17, 2008
Date Posted September 27, 2010
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = CP MEDICAL
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