Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plate
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.
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: The recall involves a medical device with a manufacturing defect (incorrect pressure plate) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs (REF 21-7100-24, 100mL) due to a manufacturing defect. The company became aware that certain Non Flow-Stop CADD Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
The recall affects 1,148,189 units distributed worldwide, including the United States and numerous international locations. All lot numbers are included in this recall. These devices are intended for use with CADD pumps, excluding CADD-Micro, CADD-MS 3, and CADD-TPN pumps.
Consumers and healthcare providers should stop using the affected devices and contact Smiths Medical ASD Inc. for further instructions or a replacement.
The recalled product
- Product
- CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 1,148,189
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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