CADD 100 mL flow stop reservoirs recalled over weakened bag welds

Plain-English summary

The Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer, including a non-vented stopper, 100 mL, product code 21-7302-24, UDI/DI 10610586027239, is being recalled. Affected lot numbers include 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593 and 6005601, with the full list in the recall notice. The recall covers 987,911 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. 100mL, Product Code 21-7302-24

Manufacturer

ICU Medical Inc.

Category

Medical Device — Infusion Supplies

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.

Distribution

Distribution scope not specified by the agency.

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