The Recall Desk

FDA (Devices) recall action 63361

Sorin Group USA, Inc. recalled 2 products on 2012-10-31

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
2012-10-31
Critical
0
Units
3,020

Why these products were recalled

Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.

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)··2012-10-31

    Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in…
    Category
    Distribution
    23 states
  • HighFDA (Devices)··2012-10-31

    Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish Reducer Connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting…
    Category
    Distribution
    23 states