PlainRecalls
FDA Devices Moderate Class II Ongoing

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

Reported: January 22, 2025 Initiated: December 3, 2024 #Z-0950-2025

Product Description

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

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
350 units
Distribution
Domestic: Nationwide Distribution
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery. Recalled by Sklar Instruments. Units affected: 350 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-0950-2025.