The Recall Desk

FDA (Devices) recall action 73743

Windstone Medical Packaging, Inc. recalled 3 products on 2016-06-08

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-06-08
Critical
0
Units
596

Why these products were recalled

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

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

1–3 of 3

  • HighFDA (Devices)··2016-06-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling specific Laparotomy Packs because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2016-06-08

    Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2016-06-08

    Windstone Medical Recalls General Surgery Packs with Medtronic Sponges

    Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.

    Product
    General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
    Category
    Distribution
    2 states