FDA Medical Device Recalls (openFDA)
C P Medical: 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.
- Recall number
- Z-2582-2010
- Recalling firm
- C P Medical
- 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.
- Status
- Terminated
- Initiated
- 2008-09-17
- Posted
- 2010-09-27
- Terminated
- 2010-09-28
- Reason
- Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.
- 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
- 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.
- Lot, serial or model codes
- Lot number L0535440, EXP 2009-11.
- 510(k) numbers
- ["K013274"]
- PMA numbers
- not on file
- Product code
- NEW
- Firm FEI
- 3002609049
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28