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U.S. Department of Health and Human Services

Class 2 Device Recall Ivalon

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 Class 2 Device Recall Ivalonsee related information
Date Initiated by FirmOctober 22, 2024
Date PostedJanuary 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0800-2025
Recall Event ID 95909
Product Classification Sponge, ophthalmic - Product Code HOZ
ProductIvalon 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
Code Information LOT NUMBER: 24F1638
FEI Number 1219313
Recalling Firm/
Manufacturer		 Carwild Corporation
3 State Pier Rd
New London CT 06320-5817
For Additional Information ContactSAME
860-442-4914
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionCarwild 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 .
Quantity in Commerce140 units
DistributionIL, FL, SC. PA, AL Foreign: Netherlands
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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