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
Reported: February 12, 2020 Initiated: January 13, 2020 #Z-1097-2020
Product Description
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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 15150
- Distribution
- Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 15150.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1097-2020.
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