FDA-Device2024-10-30Class II
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Smiths Medical ASD Inc.
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.
Sold states
Worldwide distribution.
Affected count
120960 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2025Don't want to check this manually?
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