The Recall Desk

FDA (Devices) recall action 67733

Teleflex Medical recalled 6 products on 2014-04-02

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2014-04-02
Critical
0
Units
193,626

Why these products were recalled

The products are being recalled because they did not meet minimum needle attachment strength requirements.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect

    Teleflex Medical is recalling non-absorbable polypropylene sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated fo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect

    Teleflex Medical is recalling non-absorbable poly(ethylene terephthalate) surgical sutures because they did not meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polye
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects

    Teleflex Medical is recalling 32,271 units of absorbable polyglycolic acid sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated fo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect

    Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-mol
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures

    Teleflex Medical is recalling 32,271 units of non-absorbable polyamide surgical sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue app
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-04-02

    Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect

    Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx
    Category
    Distribution
    0 states