Sklar Instruments: Device Recall

Recall #Z-0933-2025 · 12/03/2024

Class II: Risk

Recall Details

Recall Number
Z-0933-2025
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
1050 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 ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

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.