The Recall Desk

FDA (Devices) recall action 76327

Covidien LLC recalled 2 products on 2017-03-15

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
2017-03-15
Critical
0
Units
1,154,350

Why these products were recalled

Sterility compromised due to breach in sterile barrier

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.

1–2 of 2

  • SevereFDA (Devices)··2017-03-15

    FDA Recalls Premier Guard Drape Due to Sterility Compromise

    The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.

    Product
    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-03-15

    FDA Recalls Premier Guard Sterile Drapes Due to Sterility Compromise

    The FDA is recalling Premier Guard Sterile Drapes because the sterile barrier was breached, compromising sterility. The recall covers 1,111,600 units distributed nationwide.

    Product
    Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Distribution
    0 states