Class 2 Device Recall SURGIFOAM" Powder

• Date Initiated by Firm: April 23, 2024
• Date Posted: May 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1881-2024
• Recall Event ID: 94496
• PMA Number: P990004
• Product Classification: Agent, absorbable hemostatic, collagen based - Product Code LMF
• Product: SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
• Code Information: Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
• Recalling Firm/ Manufacturer: Ethicon, Inc.; Us Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Ethicon Resource Department; 908-218-0707
• Manufacturer Reason for Recall: Some applicator tips from these lots had open seals.
• FDA Determined Cause: Under Investigation by firm
• Action: On April 19, 2024 Urgent Medical Device Recall (Removal) letters were distributed to distributors and customers. Actions to be taken by customer: 1. Examine your inventory immediately to determine if you have product subject to this recall 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 2) confirming receipt of this notice and fax or email to Sedgwick at 844-656-8030 or ethicon4908@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 SURGIFOAM" Absorbable Gelatin Powder Kits subject to this recall that are in inventory immediately. To receive credit, customers must return product subject to this recall no later than July 31, 2024. The entire kit must be returned. Any non-affected product and any product returned after the date specified will not receive credit. 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 866-912-8413. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assista
• Quantity in Commerce: 5,184 units
• Distribution: US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI.
• 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.

• PMA Database: PMAs with Product Code = LMF and Original Applicant = Ferrosan Meidcal Devices A/S