Z-0145-2025 Class II Ongoing
FDA device recall Z-0145-2025 was initiated by Smiths Medical ASD Inc. on Jul 18, 2024 and is designated Class II. Reason for recall: Uncertainty in the seal integrity of the sterile packaging. The recall status is ongoing. Affected quantity: 9,133 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Jul 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,133 units
Product Description
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 35019315011003, Lot Numbers: 4131841, UDI/DI 35019315022405, Lot Numbers: 4122012, 4133227
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0145-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026