Z-2582-2010

Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable...

Name: Z-2582-2010 Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable...
Creator: C P Medical
Published: 2008-09-17
License: https://open.fda.gov/license/

C P Medical Inc. / initiated 2008-09-17 / Terminated / root cause: supplier

FDA source

C P Medical began a recall of Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5... on 2008-09-17. The reason FDA records is "Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2582-2010
Status: Terminated
Initiated: 2008-09-17
Posted: 2010-09-27
Terminated: 2010-09-28
Recalling firm: C P Medical Inc.
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.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.
Root cause tag: supplier
FDA root 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.
Product codes and lots: Lot number L0535440, EXP 2009-11.

Product code NEW

K013274Class IIMono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,sterileCp Medical / cleared 2001-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)