Z-0016-2025 Class II Ongoing
FDA device recall Z-0016-2025 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: 8976 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Jun 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8976 units
Product Description
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
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 NA, Lot/Serial Numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, 4052407
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0016-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026