Z-1096-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,948
Product Description
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
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.
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.
Code Information
REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029)