Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.
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, and the source text describes a risk-of-harm product (medical device) with manufacturing defects where no specific injuries or illnesses have been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD(R) Medication Cassette Reservoirs with clamp and female Luer, reference number 21-7002-24. The affected units are sterile, ethylene oxide sterilized, and prescription-only. The recall involves 17,280 units from lot number 16X659.
The recall was initiated because the medication cassette reservoirs may have been manufactured with the incorrect pressure plate. Additionally, the tubing used on the cassette may have been routed incorrectly. These manufacturing defects could potentially affect the performance of the medical device.
The affected units were distributed in Japan, China, and the United States. Consumers and healthcare providers should stop using the affected CADD Medication Cassette Reservoirs and contact Smiths Medical ASD Inc. for further instructions or a replacement.
The recalled product
- Product
- CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 17,280
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)
- lot number 16X659
Distribution
Distribution scope not specified by the agency.
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