Z-1697-2024 Class II Ongoing
FDA device recall Z-1697-2024 was initiated by Covidien, LP on Jan 25, 2024 and is designated Class II. Reason for recall: One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in… The recall status is ongoing. Affected quantity: 36 total, OUS distribution only.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Jan 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 total, OUS distribution only
Product Description
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
Reason for Recall
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
Distribution Pattern
International distribution in the countries of Portugal and Italy.
Code Information
UDI-DI 20884521086422 Lot D2F2101RY
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1697-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026