Device Recall MonoDox Synthetic Absorbable Suture

  • Model / Serial
    M397, M398 (Butler code 029254)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}). || Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***". || 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. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source
    USFDA