Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Company
- Carwild Corporation
- Recall Initiated
- October 22, 2024
- Posted
- January 2, 2025
- Recall Number
- Z-0799-2025
- Quantity
- 300 units
- Firm Location
- New London, CT
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.
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Lot / Code Info
LOT NUMBER: 24G1739
Root Cause
Equipment maintenance
Action Taken
Carwild Corp issued letter On Behalf Of First Aid Bandage Company (Fabco) Recall Notice Urgent via email 12/22/24. Letter states reason for recall, health risk and action to take; Cease Further Distribution Or Use Of Any Remaining Product Immediately . Distributors are responsible to notify all your customers who may have received this product. Please provide shipment history. Call for questions or additional information: Regulatory 1-860-442-4914 x111 Customer Service 1-860-442-4914 x110 .
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