FDA recall Z-1097-2020

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

Reason for recall

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.

Distribution

Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Key facts

Status: Terminated
Initiation date: 2020-01-13
Report date: 2020-02-12
Termination date: 2021-08-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1097-2020