Smiths Medical Recalls CADD Administration Sets with Flow Stop
Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.
What this means for you
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 involves a medical device where under-delivery of medication could lead to adverse health consequences, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
Smiths Medical ASD, Inc. is recalling CADD Administration Sets with Flow Stop, including specific product reorder numbers, due to a potential for under-delivery of medication. The affected devices are CADD Medication Cassette Reservoirs with Flow Stop, which are designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached. The Flow Stop component is located on the reservoir housing and must be activated by removing a blue "CLIP" before the reservoir can be attached to the pump.
The recall covers 13,696,830 units with expiration dates on or before March 2021. These devices were distributed in all states in the continental USA, including DC and Puerto Rico, except Delaware. They were also distributed in numerous countries outside the US, including Canada, the United Kingdom, Germany, and Japan.
Consumers and healthcare providers should stop using the affected CADD Administration Sets with Flow Stop and contact Smiths Medical ASD, Inc. for further instructions or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 13,696,830
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)
- Devices with an expiration date on or before March 2021
Distribution
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