Z-0010-2025 Class II Ongoing
FDA device recall Z-0010-2025 was initiated by Smiths Medical ASD Inc. on June 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 leakage… The recall status is ongoing. Affected quantity: 125928 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- June 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125928 units
Product Description
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
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 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238