CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
FDA Recall Z-0010-2025 · Posted 2024-10-18
Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2024-06-26
Product Quantity125928 units
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.
Firm Action
Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers.
For further inquires:
Product complaints or adverse events: [email protected]
1-(866)-216-8806
Additional information or technical assistance 1-(800)-241-4002, option 3
[email protected]
Root Cause
Process control
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.