Reported Jul 15, 2020 · Terminated
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during…
Dufner Instrumente GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dufner Instrumente GmbH · Fohrenstr. 9 · Tuttlingen · N/A
Is this the product you have?
- DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and
- surgical procedures Reference Number18044-23
- Lot codes and dates
- Lot Numbers8170368 and 8180673
- Amount recalled
- 30 units
Where it was sold
Why it was recalled
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
This product could cause temporary or reversible health problems — stop using it.
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