Z-1624-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2020
- Initiation Date
- February 27, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,025
Product Description
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, 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.
Distribution Pattern
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.
Code Information
1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919