Surgical spears recalled for potential sterile barrier defect
Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.
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 is a risk-of-harm product where injury has not yet been reported. A surgical instrument with a compromised sterile barrier poses a risk of infection during ophthalmic procedures, but no infections or adverse events have been reported to date.
Plain-English summary
Carwild Corporation is recalling 300 Ivalon cellulose surgical spears (Model Q604237, Lot 24G1739) intended for use during ophthalmic (eye) surgical procedures for fluid management. The devices were distributed to healthcare facilities in Illinois, Florida, South Carolina, Pennsylvania, Alabama, and the Netherlands.
The recall was issued because the package seal may be out of specification, and the sterile barrier cannot be guaranteed for the life of the product. Sterility is critical for surgical instruments used in eye procedures; non-sterile instruments could introduce infection during delicate ophthalmic surgery.
Healthcare facilities that have received these devices should verify product sterility status before use and should not use any units from Lot 24G1739 until the situation is resolved. Affected customers should contact Carwild Corporation regarding return, replacement, or clarification of which products are safe for continued use.
The recalled product
- Product
- Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
- Manufacturer
- Carwild Corporation
- Hazard
- sterile-barrier-compromise
- package-seal-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: 24G1739
Distribution
Distributed in 5 states:
- AL
- FL
- IL
- PA
- SC
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