Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate
Smiths Medical is recalling CADD Medication Cassette Reservoirs that may have been manufactured with an incorrect pressure plate. The recall covers units distributed worldwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (incorrect pressure plate) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD Medication Cassette Reservoirs with clamp and female Luer (100 mL, REF 21-7002-24). The recall was initiated because the company became aware that certain Non Flow-Stop CADD Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
The affected products are sterile, ethylene oxide (EO) sterilized, and intended for use with CADD pumps, excluding CADD-Micro, CADD-MS 3, and CADD-TPN pumps. The recall includes all lot numbers and covers approximately 111,705,35 units. Distribution was worldwide, including the United States and numerous international locations such as Canada, the United Kingdom, Germany, and Australia.
Consumers and healthcare providers should stop using the affected reservoirs and contact Smiths Medical for further instructions or a replacement. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 11,170,535
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 (1)
- All lot numbers
Distribution
Part of a larger recall action
This product is one of 3 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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