CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
This recall is currently active, issued October 18, 2024. It was issued by Smiths Medical Asd Inc..
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- June 26, 2024
- Posted
- October 18, 2024
- Recall Number
- Z-0012-2025
- Quantity
- 26160 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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
Worldwide distribution.
Lot / Code Info
UDI/DI 10610586027192, Lot Numbers: 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, 4048899
Root Cause
Process control
Action Taken
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