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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 described as a voluntary precautionary measure for a potential sterility breach without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling specific models of CBCII Wound Drains and Ambulating Bulbs. The recall is being conducted because of a potential sterility breach in the product packaging.
The affected products include the 1/4 in. Trocar with Single Drain, Curved Trocar with Wound Drain, and Double Trocar with Wound Drain. These devices feature curved or double metal trocars attached to flexible wound drain tubes, often equipped with polymeric trocar guards for safety during handling. The recall covers 1,984 boxes, containing a total of 19,840 individual units.
The products were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. The specific part number is 0215-019-000, and the recall includes a wide range of lot numbers listed in the official agency records. Healthcare providers and facilities should check their inventory for these specific part and lot numbers and stop using the affected devices if found.
The recalled product
- 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…
- 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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