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

FDA Device Recall #Z-0011-2025 — Class II — June 26, 2024

Recall Summary

Recall Number Z-0011-2025
Classification Class II — Moderate risk
Date Initiated June 26, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smiths Medical ASD Inc.
Location Minneapolis, MN
Product Type Devices
Quantity 385558 units

Product Description

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

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 Pattern

Worldwide distribution.

Lot / 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

Other Recalls from Smiths Medical ASD Inc.

Recall # Classification Product Date
Z-0147-2025 Class II smiths medical portex, Thermovent 1200, 15mm/22... Jul 18, 2024
Z-0145-2025 Class II smiths medical portex, Y' PIECE 15MM, REF 100/2... Jul 18, 2024
Z-0146-2025 Class II smiths medical portex, 'ORATOR' SPEAKING VALVE ... Jul 18, 2024
Z-0143-2025 Class II smiths medical portex, Nasopharyngeal Airway, S... Jul 18, 2024
Z-0144-2025 Class II smiths medical portex, 15mm Double Swivel Conne... Jul 18, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.