Recall Z-0928-2025— 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: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use). 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: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
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.