Smiths Medical Recalls CADD Medication Cassette Reservoirs with Incorrect Pressure Plates
Smiths Medical 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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs with clamp and female Luer (REF 21-7001-24). The recall affects 2,827,352 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because Smiths Medical became aware that certain Non Flow-Stop CADD Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. The agency classification for this recall is Class II.
Consumers and healthcare facilities should stop using the affected devices and contact Smiths Medical ASD Inc. for further instructions or a replacement.
The recalled product
- Product
- CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps…
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 2,827,352
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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