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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary action for a potential sterility breach. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain and Double Trocar with Wound Drain devices. The recall is being conducted because of a potential sterility breach in the packaging of these medical devices.
The affected products include 120 boxes, containing 1,200 units each, distributed worldwide to the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. The specific part number is 0225-019-000, and the recall covers specific lot numbers listed in the agency's official records.
Healthcare providers and facilities should stop using the affected devices and contact Stryker Instruments for further instructions on the recall process. This action is taken to ensure patient safety by addressing the potential compromise in the sterile packaging.
The recalled product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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