Stryker Recalls Wound Drains and Ambulating Bulb for Sterility Breach
Stryker Instruments is voluntarily recalling specific wound drain and ambulating bulb products 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 involves a potential sterility breach in medical devices, which poses a risk of infection or harm, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb. The recall is being conducted because of a potential sterility breach in the packaging of these medical devices.
The affected products include the 1/4 in. Double Trocar with Wound Drain and the Curved Trocar with Wound Drain. The source text identifies Part Number 0215-019-200 and Lot Number 14122012 as part of the recall scope. The quantity involved is 4 boxes, containing 40 units each.
These products were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. Healthcare facilities and patients who have used these specific devices should contact Stryker Instruments for further instructions on how to proceed.
The recalled product
- Product
- 1/4 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: 0215-019-200 and lot numbers: 14122012
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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