CADD Medication Cassette Reservoir Recall Due to Defective Weld Joint
Smiths Medical is recalling CADD Medication Cassette Reservoirs with defective weld joints that may cause medication leakage. The issue affects 8,976 units distributed worldwide.
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 an FDA Class II recall of a medical infusion device with a manufacturing defect that could result in medication leakage. No illnesses or injuries have been reported, and the hazard remains theoretical; therefore, it is classified as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs, 50 mL, Product Code 21-7301-24JP. The devices may exhibit weakened weld joints between the medication bag and tubing due to production equipment malfunction during manufacturing.
This weld defect could result in medication leakage. The recall affects 8,976 units with lot/serial numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, and 4052407. The affected units were distributed worldwide.
No illnesses or injuries have been reported in connection with this defect. The Food and Drug Administration classified this as a Class II recall.
The recalled product
- Product
- CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- medication-leakage
- manufacturing-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 (9)
- UDI/DI NA
- Lot/Serial Numbers: 4013366
- 4034019
- 4037749
- 4034021
- 4040248
- 4042841
- 4048891
- 4052407
Distribution
Distribution scope not specified by the agency.
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