Class 2 Device Recall First Aid Sterile Gauze Pad

• Date Initiated by Firm: October 16, 2018
• Create Date: November 30, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0525-2019
• Recall Event ID: 81555
• Product Classification: Gauze / sponge,nonresorbable for external use - Product Code NAB
• Product: Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
• Code Information: ASO Item No. 780655, Batch/Lot # 2384-20180524
• FEI Number: 1038758
• Recalling Firm/ Manufacturer: ASO, LLC; 300 Sarasota Center Blvd; Sarasota FL 34240-9381
• For Additional Information Contact: Steve Walter; 941-378-6649
• Manufacturer Reason for Recall: Potential that gauze pads may not be fully sterilized
• FDA Determined Cause: Under Investigation by firm
• Action: ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form.
• Quantity in Commerce: 218 cases (72, 10-ct boxes per case)
• Distribution: Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.
• 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.