Z-0018-2025 Class II Ongoing
FDA device recall Z-0018-2025 was initiated by Smiths Medical ASD Inc. on Jun 26, 2024 and is designated Class II. Reason for recall: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication… The recall status is ongoing. Affected quantity: 120960 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Jun 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120960 units
Product Description
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Reason for Recall
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0018-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026