Sklar Instruments: Device Recall

Recall #Z-0938-2025 · 12/03/2024

Class II: Risk

Recall Details

Recall Number
Z-0938-2025
Classification
Class II
Product Type
Device
Recalling Firm
Sklar Instruments
Status
Ongoing
Date Initiated
12/03/2024
Location
West Chester, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
150 units

Reason for Recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Product Description

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

Distribution Pattern

Domestic: Nationwide Distribution

Other Recalls by Sklar Instruments

View all recalls by Sklar Instruments →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.