healthClass IIRecalled on Sep 10, 2025

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer

🔢 289098 units

Sold At: ICU Medical Inc.(Worldwide distribution.)

Recall #: FDA-DEVICE-Z-2524-2025

Source: FDA-ENFORCEMENT

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer

Product Identification

Lot/Batch Codes:
UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695

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Summary

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact ICU Medical Inc. for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.