Recall Z-0932-2025— Sklar Instruments
Class II · Ongoing
Class II FDA medical device recall by Sklar Instruments, initiated 2024-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures. Reason: Reports of various packaging issues that may result in a breach of the sterile barrier..
- Recalling firm
- Sklar Instruments
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-03
- Firm location
- West Chester, PA, United States
Product description
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
Reason for recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.