Recall Z-1625-2020— Gentell, Inc
Class II · Ongoing
Class II FDA medical device recall by Gentell, Inc, initiated 2020-02-27. FDA's recall record names no specific 510(k) clearance for this event. 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 degree burns and skin tears. It provides a moist wound environment for healing.. Reason: During an FDA audit, it was discovered that the product was not properly registered with FDA..
- Recalling firm
- Gentell, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-02-27
- Firm location
- Bristol, PA, United States
Product description
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 degree burns and skin tears. It provides a moist wound environment for healing.
Reason for recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.