Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
FDA Recall Z-0800-2025 · Posted 2025-01-02
Recalling FirmCarwild Corporation
Recall StatusOpen, Classified
Product CodeHOZ
Date Initiated2024-10-22
Product Quantity140 units
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.
Firm Action
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
.
Root Cause
Equipment maintenance
Distribution Pattern
IL, FL, SC. PA, AL Foreign: Netherlands
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.