Z-0799-2025Class II

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid...

Name: Z-0799-2025 Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid...
Creator: Carwild Corporation
Published: 2024-10-22
License: https://open.fda.gov/license/

Carwild Corp. / initiated 2024-10-22 / Open, Classified / root cause: manufacturing process

FDA source

Carwild Corporation began a recall of Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237 on 2024-10-22. FDA classified it as Class II and gives the reason as "Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0799-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-22
Posted: 2025-01-02
Recalling firm: Carwild Corp.
Product: Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Product code: HOZ Sponge, Ophthalmic
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
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 .
Quantity in commerce: 300 units
Distribution: IL, FL, SC. PA, AL Foreign: Netherlands
Product codes and lots: LOT NUMBER: 24G1739

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0798-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2025-01-02
Z-0799-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2025-01-02
Z-0800-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-08	2025-01-02

Product code HOZ

K971832Class IIIvalon Pva Surgical Spear, Ivalon Eye Drain, 80Cc, Ivalon Eye Drain, 400Cc, Ivalon Eye WickM-Pact Worldwide Management Corp. / cleared 1997-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)