Smiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk
Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.
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 involves a medical device with a potential leak hazard, which poses a risk of harm, but the source explicitly states that no serious injuries or deaths have been reported, fitting the criteria for a High severity score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling specific lots of 50mL CADD Medication Cassette Reservoirs. The recall involves reference numbers 21-7001-24 and 21-7301-24, which are sterile and available by prescription only. The affected lots are 14X297 and 14X323 for reference 21-7001-24, and lot 14X324 for reference 21-7301-24.
The recall was initiated because some cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
A total of 48,208 units were distributed, with 17,040 units in the United States and 31,168 units outside the US. The products were distributed nationwide in the US and to various countries including Canada, the United Kingdom, and Germany. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and contact Smiths Medical for instructions on how to proceed.
The recalled product
- Product
- CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pumps
- Hazard
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)
- 21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324
Distribution
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