Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Nu
FDA device recall Z-0799-2025 · posted 2025-01-02 · Open, Classified
Recall details
- Recalling firm
- Carwild Corporation
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- HOZ
- Quantity affected
- 300 units
- Distribution
- IL, FL, SC. PA, AL Foreign: Netherlands
- Date initiated
- 2024-10-22
- Date posted
- 2025-01-02
- Location
- New London, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK (K971832) | M-Pact Worldwide Management Corp. | 1997-07-31 |