Recall Z-0798-2025— Carwild Corporation

Name: FDA recall Z-0798-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-22

Class II · Ongoing

Class II FDA medical device recall by Carwild Corporation, initiated 2024-10-22. It names one FDA 510(k) clearance: K971832. Product: Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206. Reason: Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product..

Recalling firm: Carwild Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-10-22
Firm location: New London, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K971832 — IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKM-Pact Worldwide Management Corp.·cleared 1997-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.