Device product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Z-1098-2025
Product summary
- Firm
- Ethicon, LLC
- Event
- Event 96127
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48
- Official record key
device-enforcement:Z-1098-2025
Official wording
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.
Code information: REF/GTIN/Lot(expiration): W8003T/10705031231658/103GT2(8/31/2029)
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.
Derived failure modes
-
Labeling or packaging
open seal
-
Sterility assurance
breach in sterility