Z-0013-2025 Class II Ongoing

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
June 26, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
119535 units

Product Description

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

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.

Code Information

UDI/DI 10610586027215, Lot Numbers: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4040247, 3983339, 3983338, 3983340, 4013367, 4013366, 3988532-ENG, 3983337, 4052406, 4042840, 4052407, 4052408, 4042842, 4048891, 4052409