Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydro

FDA device recall Z-1624-2020 · posted 2020-03-05 · Open, Classified

Recall details

Recalling firm

Gentell, Inc

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

FRO

Quantity affected

20,025

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, Ba

Date initiated

2020-02-27

Date posted

2020-03-05

Location

Bristol, PA