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U.S. Department of Health and Human Services

Class 2 Device Recall Gentell Hydrogel Ag

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  Class 2 Device Recall Gentell Hydrogel Ag see related information
Date Initiated by Firm February 27, 2020
Date Posted March 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-1623-2020
Recall Event ID 85034
Product Classification Dressing, wound, drug - Product Code FRO
Product 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, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.
Code Information 1134117 1101918 1107518 1114918 1121118 1127718 1131018 1133218 1135118 1105919 1118819 1121419 1124919
Recalling Firm/
Gentell, Inc
2701 Bartram Rd
Bristol PA 19007-6810
For Additional Information Contact Valerie Falkenbert
Manufacturer Reason
for Recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
FDA Determined
Cause 2
No Marketing Application
Action On February 27, 2020, the firm notified customers by distributing Urgent Medical Device Recall letters. Customers were informed that the products were not properly registered with the FDA, and that the firm is discontinuing the product permanently. Customers were asked to quarantine and return the product. To return product, customers are to complete the response form included with the letter and fax or email it back to the firm. A quality representative will contact customers with a return goods authorization number, provide instruction for the return of the product(s) to Gentell, and arrange for any refund that may be due. The response form should be completed and returned even if customers have no affected stock on hand. Customers with questions should contact Valerie Falkenberg, Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time, 800-840-9041 or vfalkenberg@gentell.com.
Quantity in Commerce 53,134
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.