Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalm
Summary
The FDA issued a Class II for Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 by Carwild Corporation. Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product..
Details
Source
Device Recall
External ID
Z-0800-2025
Action Date
2025-01-08
Status
Ongoing
Category
device
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
Lot/Code Info: LOT NUMBER: 24F1638
Quantity Affected: 140 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.
Distribution
IL, FL, SC. PA, AL Foreign: Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-22
Company
New London, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Carwild Corporation has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Carwild Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Carwild Corporation have FDA actions?
Carwild Corporation has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0800-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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