Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise
Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm product—a surgical device with a compromised sterile barrier due to packaging defects. No illnesses or injuries have been reported, and the hazard is potential rather than confirmed, placing this at High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Carwild Corporation is recalling the Ivalon Eye Wick 20cm (Model Q604206), an ophthalmic surgical device intended for removal and collection of fluids during ophthalmic surgical procedures. The recall affects 120 units distributed to facilities in Illinois, Florida, South Carolina, Pennsylvania, and Alabama, as well as the Netherlands (Lot Number 24G1880).
The device packages have been found with seals that are out of specification. This defect means the sterile barrier cannot be guaranteed for the life of the product, potentially allowing contamination if the seal fails.
Healthcare facilities and surgical centers that have received affected units should quarantine them and contact Carwild Corporation for return and replacement instructions. No illnesses or injuries related to this packaging defect have been reported to date.
The recalled product
- Product
- Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
- Manufacturer
- Carwild Corporation
- Hazard
- sterile-barrier-compromise
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT NUMBER: 24G1880
Distribution
Distributed in 5 states:
- AL
- FL
- IL
- PA
- SC
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