Class II

Medical Device Recall: ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Smiths Medical ASD Inc. · June 26, 2024

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 Affected

2881080 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0017-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.