FDA (Devices) recall action 70841

Stryker Instruments Div. of Stryker Corporation recalled 12 products on 2015-05-13

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products: 12
Announced: 2015-05-13
Critical: 0
Units: —

Why these products were recalled

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

The agency’s own wording, quoted from the enforcement report.

1–12 of 12

ModerateFDA (Devices)··2015-05-13
Stryker Recalls Curved Trocar Wound Drains for Sterility Breach
Stryker is voluntarily recalling 3/16 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.
Product
3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection
Category
Distribution
0 states
ModerateFDA (Devices)··2015-05-13
Stryker Recalls Curved Trocar Wound Drains for Sterility Breach
Stryker Instruments is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.
Product
1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Product
1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains and Ambulating Bulb for Sterility Breach
Stryker Instruments is voluntarily recalling specific wound drain and ambulating bulb products due to a potential sterility breach in the packaging.
Product
1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Product
3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Trocar Wound Drains Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.
Product
3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from t
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Product
1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Ambulating Bulbs Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.
Product
Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in
Category
Distribution
0 states
HighFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling specific wound drain devices because of a potential sterility breach in the packaging.
Product
1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the
Category
Distribution
0 states
ModerateFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.
Product
3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection
Category
Distribution
0 states
ModerateFDA (Devices)··2015-05-13
Stryker Recalls Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.
Product
1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from th
Category
Distribution
0 states
ModerateFDA (Devices)··2015-05-13
Stryker Recalls Curved Trocar Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling 1/8 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.
Product
1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection f
Category
Distribution
0 states