Stryker Recalls Ambulating Bulbs Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains 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 involves a potential sterility breach in a medical device, which poses a risk of infection (harm) to patients, but the source text does not report any specific 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 Ambulating Bulb, a component used with the CBCII Wound Drains. The recall is being conducted due to a potential sterility breach in the packaging.
The Ambulating Bulb consists of a suction reservoir, PVC tubing, a slide clamp, and a female connector. It is used to connect to the CBCII evacuator tube to collect wound drainage. The affected product is identified by Part Number 0225-028-852 and specific lot numbers listed in the recall documentation.
The recall covers 2,575 boxes (25,750 units each) distributed worldwide, including the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. Healthcare facilities and consumers should stop using the affected units and contact Stryker Instruments for instructions on return or replacement.
The recalled product
- Product
- Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Wound Care
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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