The Recall Desk

FDA (Devices) recall action 73318

Applied Medical Technology Inc recalled 4 products on 2016-05-11

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-05-11
Critical
0
Units
12,451

Why these products were recalled

The firm received a complaint of an open pouch which breaches the sterilization validation.

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

1–4 of 4

  • HighFDA (Devices)··2016-05-11

    Applied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 5,334 units of TLC Self Retaining Retractor Systems because a complaint reported an open pouch that breaches sterilization validation.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2016-05-11

    Applied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach

    Applied Medical Technology is recalling 3,754 units of TLC Self-Retaining Retractor Frames because a complaint reported an open pouch, which breaches sterilization validation.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2016-05-11

    Applied Medical Recalls Wilson Penile Implantation System Retractor Frame

    Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2016-05-11

    Applied Medical Recalls Wilson Implantation System Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System after a complaint revealed an open pouch that breached sterilization validation.

    Product
    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Distribution
    28 states