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FDA (Device enforcement)Recalled 2024-06-26class ii

Smiths Medical ASD Inc.: CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 385558 units Lot/code info: 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

UPC codes

10610586027239

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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