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 3/5 (High).
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. The hazard involves a potential sterility breach in a medical device, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb. The recall is issued because of a potential sterility breach in the product packaging.
The affected products include the 3/16 in. Round Drain with Trocar, Curved Trocar with Wound Drain, and Double Trocar with Wound Drain. These devices feature metal trocars and flexible wound drain tubes, some equipped with polymeric trocar guards for protection during handling. The recall involves 648 boxes, containing 6,480 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. Specific part number 0215-031-000 and multiple lot numbers are affected. Healthcare providers and consumers should stop using these products and contact Stryker Instruments for further instructions.
The recalled product
- 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…
- 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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