FDA-Device2020-02-12Class II
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Stryker Instruments Div. of Stryker Corporation
Hazard
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Sold states
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Affected count
15150
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2020Don't want to check this manually?
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