The Recall Desk

FDA (Devices) recall action 71880

Elcam Medical, Inc. recalled 2 products on 2015-09-16

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
2015-09-16
Critical
0
Units
7,969,680

Why these products were recalled

Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

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)··2015-09-16

    Elcam Medical stopcock recall due to punctured blister packages

    Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2015-09-16

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging

    Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
    Category
    Distribution
    3 states