Recall Z-0950-2025— 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: 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: 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.