CADD Medication Cassette Reservoir (Smiths Medical) – Weld Joint Weakness (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
UDI/DI 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238
Products Sold
UDI/DI 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 due to Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malf. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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: productcomplaints@icumed.com 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 tsc.support@icumed.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026