Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Reported: January 8, 2025 Initiated: October 22, 2024 #Z-0799-2025
Product Description
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Reason for Recall
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Details
- Recalling Firm
- Carwild Corporation
- Units Affected
- 300 units
- Distribution
- IL, FL, SC. PA, AL Foreign: Netherlands
- Location
- New London, CT
Frequently Asked Questions
What product was recalled? ▼
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237. Recalled by Carwild Corporation. Units affected: 300 units.
Why was this product recalled? ▼
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2025. Severity: Moderate. Recall number: Z-0799-2025.
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