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Recall Observatory FDA recall evidence

Device product

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Z-0011-2025

June 26, 2024

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 95305
Status
Ongoing
Classification
Class II
Quantity
385558 units
Official record key
device-enforcement:Z-0011-2025

Official wording

Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information: UDI/DI 10610586027239, Lot Numbers: 3971709, 3983317, 3983316, 3983315, 3983318, 3983327, 3983320, 3983321, 3983323, 3983328, 3983322, 4013357, 3983325, 3983324, 3983329, 3983326, 3983330, 3983332, 3983331, 3983334, 4013356, 4034028, 4013355, 4046848, 4013353, 4013358, 3983335, 4013360, 4013361, 4013359, 4013363, 4013362, 4013377, 4013374, 4013376, 4013378, 4013373, 4013375, 4034023, 4019430, 4019427, 4019428, 4034024, 4019429, 4034029, 4037751, 4034026, 4037754, 4037753, 4034031, 4034030, 4034025, 4037757, 4046846, 4037752, 4037756, 4040249, 4037755, 4042843, 4040250, 4040251, 4046845, 4042844, 4046847, 4052411, 4048893, 4066532, 4048892, 4048894, 4052410, 4053920, 4052412, 4052413, 4060911

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.