Recall Z-1623-2020 ยท FRO Dressing, Wound, Drug
Gentell, Inc
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.
| Date | Mar 5, 2020 (initiated Feb 27, 2020) |
| Status | Open, Classified |
| Reason | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.