Device Recall Polyglycolic Acid (PGA) Absorbable Suture

  • Modèle / numéro de série
    398A and 453A
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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 3/0 (2.0 Metric), NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid). || Product is labeled in part: "***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***". || 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


  • Adresse du fabricant
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source