Recall Z-0948-2025— Sklar Instruments
Class II · Ongoing
Class II FDA medical device recall by Sklar Instruments, initiated 2024-12-03. It names one FDA 510(k) clearance: K772229. Product: ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
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.