The Recall Desk

FDA (Devices) recall action 67973

Teleflex Medical recalled 2 products on 2014-05-07

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-05-07
Critical
0
Units
14,760

Why these products were recalled

The product did not meet minimum and/or average minimum Teleflex resorption 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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-05-07

    Teleflex Recalls Dekna-lok Sutures for Failing Resorption Strength Requirements

    Teleflex Medical is recalling 7,380 units of Dekna-lok sutures because they did not meet minimum resorption strength requirements. The affected products were distributed in the US, Ireland, and Singapore.

    Product
    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2014-05-07

    Teleflex Recalls CAPIO Absorbable Surgical Sutures for Strength Defects

    Teleflex Medical is recalling CAPIO absorbable surgical sutures because they did not meet minimum resorption strength requirements. The recall affects 7,380 units distributed in the US, Ireland, and Singapore.

    Product
    CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
    Category
    Distribution
    11 states