FDA recall Z-0800-2025

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 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

Key facts

Status

Ongoing

Initiation date

2024-10-22

Report date

2025-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

New London, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0800-2025