PlainRecalls
FDA Devices Moderate Class II Ongoing

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

Reported: January 22, 2025 Initiated: December 3, 2024 #Z-0926-2025

Product Description

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

Reason for Recall

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

Details

Recalling Firm
Sklar Instruments
Units Affected
125 units
Distribution
Domestic: Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures). Recalled by Sklar Instruments. Units affected: 125 units.
Why was this product recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0926-2025.