The Recall Desk

FDA (Devices) recall action 87859

Windstone Medical Packaging, Inc. recalled 2 products on 2021-06-23

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
2021-06-23
Critical
0
Units
304

Why these products were recalled

Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld

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

  • HighFDA (Devices)··2021-06-23

    Angio Pack surgical kits recalled for insufficient welds in tubing

    Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.

    Product
    Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2021-06-23

    Surgical Angio Pack Kits Recalled Due to Incomplete Angio Tubing Weld

    Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.

    Product
    Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22…
    Category
    Distribution
    1 state