ECONO STERILE medical procedure kits labeled as: 1) recall: Sterility Concern
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY…
Why was ECONO STERILE medical procedure kits labeled as: 1) recalled?
Reports of various packaging issues that may result in a breach of the sterile barrier.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY…
- Recalling firm
- Sklar Instruments
- Quantity
- 0 units
- Distribution
- Domestic: Nationwide Distribution
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)