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.

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