—#209944

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081156
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: productcomplaints@icumed.com 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 tsc.support@icumed.com

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-06-26
Posted by FDA: 2024-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209944. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.