Recall Z-0800-2025— Carwild Corporation
Class II · Ongoing
Class II FDA medical device recall by Carwild Corporation, initiated 2024-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product..
- Recalling firm
- Carwild Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-22
- Firm location
- New London, CT, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.