Gentell Hydrogel Ag Saturated Gauze Recalled for FDA Registration Deficiency
Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag Saturated Gauze because the product was not properly registered with the FDA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and registration issue (failure to register with FDA) rather than a product defect or safety hazard, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Gentell, Inc. is recalling 6,433 units of Gentell Hydrogel Ag 4x8 Saturated Gauze, model no. GEN-11820. The product is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, and skin tears.
The recall was initiated after an FDA audit discovered that the product was not properly registered with the FDA. The affected units were distributed worldwide, including in the United States and various international locations.
Healthcare professionals and consumers should stop using the affected products and contact Gentell, Inc. for further instructions or a refund.
The recalled product
- Product
- Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second de
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 6,433
Distribution
Part of a larger recall action
This product is one of 4 recalled by Gentell, Inc 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.
See all 4 products in this recall →Related recalls
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