Flow stop cassette reservoirs recalled because medication bag welds may weaken
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; leakage from a medication reservoir could interrupt or reduce a dose, and no injuries are reported.
Plain-English summary
The Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer, including a non-vented stopper, 50 mL, product code 21-7301-24, UDI/DI 10610586027215, is being recalled. Affected lot numbers include 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023 and 6022024, with the full list in the recall notice. The recall covers 211,750 units distributed worldwide.
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing, which could result in medication leakage along the bag perimeter. The FDA classified the action as Class II.
Hospitals, infusion providers and home care patients should check lot numbers against the recall notice and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
- Manufacturer
- ICU Medical Inc.
- Hazard
- weld-failure
- medication-leakage
- infusion-supplies
- class-ii
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 (20)
- UDI/DI 10610586027215
- Lot Numbers: 6005583
- 6005584
- 6005588
- 6012462
- 6022021
- 6022022
- 6022023
- 6022024
- 6022025
- 6022026
- 6022028
- 6022030
- 6022031
- 6022032
- 6026837
- 6026839
- 6037765
- 6037768
- 6037771
Distribution
Distribution scope not specified by the agency.
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