RecallRadar

FDA Device recall Z-0013-2025

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

On 2024-10-30 the FDA classified a Class II recall of CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 by Smiths Medical Asd, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0013-2025
ClassificationClass II
Statusongoing
Initiated2024-06-26
Published2024-10-30
Last updated2026-09-13 11:57 UTC
CompanySmiths Medical Asd
Distributionn/a

Product

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

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.

Identifiers

code_info
UDI/DI 10610586027215, Lot Numbers: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0013-2025%22

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