Z-0144-2025 Class II Ongoing
FDA device recall Z-0144-2025 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: 34,141 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Jul 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,141 units
Product Description
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution Pattern
Worldwide distribution.
Code Information
a) REF 100/255/150, UDI/DI 35019315022399, Lot Numbers: 4125006; UDI/DI 35019315010990, Lot Numbers: 4159808, 4161750; UDI/DI 35019315011003, Lot Numbers: 4131840; UDI/DI 35019315018156, Lot Numbers: 4131559; UDI/DI 35019315022405, Lot Numbers: 4122011, 4127688; b) REF 100/255/150JP, UDI/DI 35019315010990, Lot Numbers: 4089148, 4107293, 4122008, 4147817, 4138707, 4159808; c) REF 100/255/150 JS, UDI/DI 35019315010990, Lot Numbers: 4122008, 4147817, 4159808
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0144-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026