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

FDA device recall Z-2582-2010 · posted 2010-09-27 · Terminated

Recall details

Recalling firm

C P Medical

Reason for recall

Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.

Action taken

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.

Root cause

Vendor change control

Status

Terminated

Product code

NEW

Quantity affected

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.

Date initiated

2008-09-17

Date posted

2010-09-27

Date terminated

2010-09-28

Location

Portland, OR

Related 510(k) clearances