Recall Z-0798-2025 ยท HOZ Sponge, Ophthalmic
Carwild Corporation
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
| Date | Jan 2, 2025 (initiated Oct 22, 2024) |
| Status | Open, Classified |
| Reason | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 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 | 120 units |
| Distribution | IL, FL, SC. PA, AL Foreign: Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK M-Pact Worldwide Management Corp., Jul 31, 1997 |