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Open, Classified

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237

FDA Recall Z-0799-2025 · Posted 2025-01-02

Recalling FirmCarwild Corporation
Recall StatusOpen, Classified
Product CodeHOZ
Date Initiated2024-10-22
Product Quantity300 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.

Firm 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 .

Root Cause

Equipment maintenance

Distribution Pattern

IL, FL, SC. PA, AL Foreign: Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKM-Pact Worldwide Management Corp. · 1997-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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