Class 2 Device Recall SURGICEL" FIBRILLAR" Absorbable Hemostat

• Date Initiated by Firm: June 11, 2024
• Date Posted: July 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2407-2024
• Recall Event ID: 94831
• Product Classification: Agent, absorbable hemostatic, non-collagen based - Product Code LMG
• Product: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
• Code Information: Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
• Recalling Firm/ Manufacturer: Ethicon Sarl, a Johnson & Johnson Company; rue du Puits-Godet 20; Neuchatel Switzerland
• For Additional Information Contact: Ethicon Resource Department; 877-384-4266
• Manufacturer Reason for Recall: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
• FDA Determined Cause: Process control
• Action: On Jun 11, 2024, URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have the lot numbers from the product codes listed in Attachment 1 on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 855-207-8799 or ethicon8137@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused SURGICEL" FIBRILLAR" Absorbable Hemostat subject to this recall that are in inventory immediately. Credit will be issued to customers who ordered directly from Ethicon. Credit or replacement product as appropriate will be provided to customers who ordered through a distributor. To receive credit or replacement product, customers must return product subject to this recall no later than September 30, 2024. Any non-affected product and any product returned after the date specified will not be eligible for credit or replacement product. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling Sedgwick at 855-620-5696. Your account number and ma
• Quantity in Commerce: 39,010 units (All US)
• Distribution: Worldwide distribution - US Nationwide and the countries of India and Japan.
• 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.