Surgical Nasal Packing Devices Recalled for Sterile Barrier Defect
Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.
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: FDA Class II sterile barrier defect on a surgical device represents risk-of-harm, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Carwild Corporation is recalling Ivalon Anatomical Nasal Packing with Airway Tube and String, Model Q770410. This surgical device is intended for use during ophthalmic procedures for fluid management. Approximately 140 units of lot number 24F1638 are subject to this recall.
The device is being recalled because the package seal may not meet specifications, which means the sterile barrier cannot be guaranteed to remain intact for the product's intended shelf life.
The affected units were distributed to healthcare facilities in Illinois, Florida, South Carolina, Pennsylvania, and Alabama, as well as to distributors in the Netherlands.
Healthcare providers with affected units should contact Carwild Corporation or the FDA for instructions regarding the affected lot and the appropriate handling of these devices.
The recalled product
- Product
- Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
- Manufacturer
- Carwild Corporation
- Affected units
- 140
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: 24F1638
Distribution
Part of a larger recall action
This product is one of 3 recalled by Carwild Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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