CADD Medication Cassette Reservoir recalled for weakened weld joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard—medication leakage from weakened welds—represents a risk-of-harm product without reported injury, meeting the 'High' severity criterion.
Plain-English summary
Smiths Medical ASD Inc. is recalling the CADD Medication Cassette Reservoir (100mL, FS, Product Code 21-7302-24JP) due to a production equipment malfunction that affected certain units. The recall involves 109,563 units distributed worldwide.
The malfunction resulted in weakened weld joints between the medication bag and tubing in certain cassettes. This defect could cause medication leakage.
The affected lot/serial numbers are: 3983315, 3971709, 3983316, 3983320, 3983329, 4013361, 4013363, 4013373, 4013377, 4013378, 4019427, 4019429, 4034028, 4037753, 4052410, 4040250, 4042843, 4048894, 4046846, 4052412, and 4052413. Affected parties should verify whether their units match these lot numbers.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 109,563
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 (20)
- UID/DI NA
- Lot/Serial Numbers: 3983315
- 3971709
- 3983316
- 3983320
- 3983329
- 4013361
- 4013363
- 4013373
- 4013377
- 4013378
- 4019427
- 4019429
- 4034028
- 4037753
- 4052410
- 4040250
- 4042843
- 4048894
- 4046846
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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