The Recall Desk

FDA (Devices) recall action 84054

Teleflex Medical recalled 3 products on 2019-12-25

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
2019-12-25
Critical
0
Units
1,578,000

Why these products were recalled

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

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.

1–3 of 3

  • HighFDA (Devices)··2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, risking needle stick injuries and sterility compromise.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-12-25

    Teleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles

    Teleflex Medical is recalling 526,000 Arrow EZ-IO Intraosseous Vascular Access System kits because safety caps may dislodge, exposing needles and compromising sterility.

    Product
    Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric
    Category
    Distribution
    0 states