Skip to content
Recall Observatory FDA recall evidence

Device product

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures

Z-0935-2025

December 03, 2024

Class II

Product summary

Firm
Sklar Instruments
Event
Event 95946
Status
Ongoing
Classification
Class II
Quantity
1050 units
Official record key
device-enforcement:Z-0935-2025

Official wording

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

Code information: 1) 96-4020M, UDI/DI 50649111476356, Lot codes: SK-125; 2) 96-4021M, UDI/DI 50649111476363, Lot codes: SK-125, SK-128; 3) 96-4022M, UDI/DI 50649111476370, Lot codes: SK-125.

Distribution pattern: Domestic: Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of the sterile barrier