Device product

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

Z-0013-2025

June 26, 2024

Class II

Product summary

Firm: Smiths Medical ASD Inc.
Event: Event 95305
Status: Ongoing
Classification: Class II
Quantity: 119535 units
Official record key: device-enforcement:Z-0013-2025

Official wording

Reason: 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.

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

Distribution pattern: Worldwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.