Bristol, PA, United States
Gentell, Inc recalls
2 recalls recorded since 2018, most recently on 26 March 2020. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 March 2020
- Reason
- During an FDA audit, it was discovered that the product was not properly registered with FDA.
- Distribution
- Worldwide distribution - US Nationwide distributions and the country of South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1907-2020, Z-1909-2020, Z-1910-2020, Z-1908-2020
- Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little
- Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little
- Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate
- Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little
Ongoing Class II Medical devices
- Recall started
- 27 February 2020
- Reason
- During an FDA audit, it was discovered that the product was not properly registered with FDA.
- Distribution
- Worldwide distribution US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1624-2020, Z-1626-2020, Z-1623-2020, Z-1625-2020
- Gentell Hydrogel Ag 4x4, model no. GEN-11420 - 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
- Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including
- Gentell Hydrogel Ag 2x2, model no GEN-11220 - 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,
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.