The Recall Desk

FDA (Devices) recall action 68026

RM Temena GmbH recalled 2 products on 2014-05-21

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
2014-05-21
Critical
0
Units
14,740

Why these products were recalled

Ultrasound needles may be defective and leak at the needle hub.

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)··2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.

    Product
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Distribution
    2 states