Dufner De Bakey Slim Needleholder Recalled for Potential Tissue Injury
Dufner Instrumente GmbH is recalling De Bakey Slim Needleholders because the tungsten carbide plate can break under pressure, potentially causing patient tissue injury.
What this means for you
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 medical device with a risk of patient tissue injury, but the source text does not report any actual injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Dufner Instrumente GmbH is recalling 30 units of the De Bakey Slim Needleholder, Reference Number 18044-23. The product is intended to hold a suturing needle for closing wounds during surgical procedures. The recall involves Lot Numbers 8170368 and 8180673, which were distributed in Illinois.
The recall is being issued because the tungsten carbide plate, which is designed to hold the sewing needle securely, can break when the needle is held under pressure. This failure can result in patient tissue injury.
Healthcare facilities and consumers who have these specific needleholders should stop using them immediately. The recalling firm, Dufner Instrumente GmbH, is responsible for managing the recall.
The recalled product
- Product
- DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
- Manufacturer
- Dufner Instrumente GmbH
- Affected units
- 30
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)
- Lot Numbers: 8170368 and 8180673
Distribution
Distributed in 1 state:
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