Device product

CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Z-0012-2025

June 26, 2024

Class II

Product summary

Firm: Smiths Medical ASD Inc.
Event: Event 95305
Status: Ongoing
Classification: Class II
Quantity: 26160 units
Official record key: device-enforcement:Z-0012-2025

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 10610586027192, Lot Numbers: 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, 4048899

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.