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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterility breach in a medical device, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs. The recall is being conducted because of a potential sterility breach in the packaging of these medical devices.
The affected products include the 1/8 in. Double Trocar with Wound Drain and the Curved Trocar with Wound Drain. These devices are used for wound drainage and feature metal trocars and flexible wound drain tubes. The recall covers 3,177 boxes (31,770 individual units) that were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Healthcare providers and facilities should check their inventory for the specific part number 0215-018-200 and the listed lot numbers to identify affected units. Patients who have had these devices implanted should contact their healthcare provider for guidance on next steps.
The recalled product
- 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
- 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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