The Recall Desk

FDA (Devices) recall action 67711

Teleflex Medical recalled 7 products on 2014-05-14

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2014-05-14
Critical
0
Units
225,897

Why these products were recalled

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

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.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil…
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.

    Product
    Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
    Category
    Distribution
    28 states
  • SevereFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2014-05-14

    Teleflex Recalls Deknatel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.

    Product
    Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.

    Product
    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE…
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the…
    Category
    Distribution
    28 states
  • SevereFDA (Devices)··2014-05-14

    Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
    Category
    Distribution
    28 states