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.
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 and involves a potential sterility breach, which poses a risk of infection (risk-of-harm product) without reported injuries in the source text.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb. The recall is being conducted due to a potential sterility breach in the packaging of these medical devices.
The affected products include the 1/4 in. Round Drain with Trocar, Curved Trocar with Wound Drain, and Double Trocar with Wound Drain. These devices feature metal trocars attached to flexible wound drain tubes, some equipped with polymeric trocar guards. The recall covers 300 boxes, containing 3,000 units each.
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 0215-032-000, and the affected lot numbers are 10098012, 10279012, 11017012, 11131012, 12033012, 12275012, 13128012, 14063012, 10165012, 10343012, 11122012, 11159012, 12137012, 13025012, 13343012, and 14105012. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- 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…
- 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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