Recall Z-1098-2025— Ethicon, LLC
Class II · Ongoing
Class II FDA medical device recall by Ethicon, LLC, initiated 2024-12-20. FDA's recall record names no specific 510(k) clearance for this event. Product: ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US. Reason: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection..
- Recalling firm
- Ethicon, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-20
- Firm location
- San Lorenzo, PR, United States
Product description
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Reason for recall
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.