CADD 50 mL cassette reservoirs recalled over weakened bag welds
Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 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 clamp and female Luer, including a non-vented stopper, 50 mL, product code 21-7001-24, UDI/DI 10610586022111, is being recalled. Affected lot numbers are 6022008, 6022009, 6037749, 6062686 and 6062687. The recall covers 29,811 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 clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
- 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 (6)
- UDI/DI 10610586022111
- Lot Numbers: 6022008
- 6022009
- 6037749
- 6062686
- 6062687
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22