Recall Z-1890-2019

Reason for recall

Observed reported incidence rate for harm associated with intraoperative bleeding

FDA-determined cause: Under Investigation by firm

Action taken

Ethicon issued Urgent Medical Device recall letter dated May 15, 2019 advising of product problem, health risk, and action to take: determine if you have product subject to this recall (removal) on hand and quarantine such product(s); 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating. 4. Complete the Business Reply Form (BRF) 5. Keep this notice visibly posted for awareness until all product subject to this recall (removal) has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. 6. Customers are required to return unused impacted ENSEAL X1 Curved Jaw Tissue Sealer in their inventory immediately. Questions customer complaints contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.