CADD Medication Cassette Reservoir weld defect poses leakage risk
Smiths Medical ASD is recalling 41,964 CADD Medication Cassette Reservoirs (50mL) due to weakened weld joints that could cause medication leakage. The defect results from a production equipment malfunction.
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: This is a FDA Class II recall for a risk-of-harm medical device where potential medication leakage is the hazard. No illnesses or injuries have been reported, placing it at the high-risk threshold per the rubric criterion for risk-of-harm products without reported harm.
Plain-English summary
Smiths Medical ASD Inc. is recalling the CADD Medication Cassette Reservoir (50mL, Product Code 21-7001-24) due to a manufacturing defect affecting the weld joint between the medication bag and tubing.
A production equipment malfunction resulted in weakened weld joints on certain units. These weakened joints could allow medication to leak during use.
The recall affects 41,964 units distributed worldwide. Affected lot numbers are 4040237, 4013368, 3983342, 4046817, 405240, and 4060903. The product is identified by UDI/DI 10610586022111.
Patients and healthcare providers currently using affected cassette reservoirs should stop use and contact their healthcare facility or the manufacturer for instructions on obtaining replacement units.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- medication-leakage
- weld-defect
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 (7)
- UDI/DI 10610586022111
- Lot Numbers: 4040237
- 4013368
- 3983342
- 4046817
- 405240
- 4060903
Distribution
Distribution scope not specified by the agency.
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