CADD Medication Cassette Reservoirs recalled for potential medication leakage
Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The defect poses a risk of medication leakage, and per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Smiths Medical ASD Inc. is recalling the CADD Medication Cassette Reservoir, 100mL (Product Code 21-7002-24). This is a component used in infusion pump systems for medication delivery.
The recalled units may contain weakened weld joints between the medication bag and tubing due to a production equipment malfunction. This weakness could result in medication leakage during use.
The recall affects 125,928 units with specific lot numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238. The products were distributed worldwide.
Healthcare providers and patients using these cassettes should immediately discontinue use of the affected lot numbers and contact Smiths Medical for replacement units.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 125,928
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI/DI 1061058602228
- Lot Numbers: 3977441
- 4013370
- 3983314
- 4013371
- 4013369
- 4013372
- 4025948
- 4033993
- 4037444
- 4040238
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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