Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used recall: Sterility Concern
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Why was Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used recalled?
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
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?
LOT NUMBER: 24G1739
- Product
- Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Recalling firm
- Carwild Corporation
- Quantity
- 300 units
- Distribution
- IL, FL, SC. PA, AL Foreign: Netherlands
- Recall date
- January 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)