Z-0145-2025 Class II Ongoing
FDA device recall Z-0145-2025 was initiated by Smiths Medical ASD Inc. on July 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
- October 30, 2024
- Initiation Date
- July 18, 2024
- Termination Date
- N/A
- 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