Device product

CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Z-0010-2025

June 26, 2024

Class II

Product summary

Firm: Smiths Medical ASD Inc.
Event: Event 95305
Status: Ongoing
Classification: Class II
Quantity: 125928 units
Official record key: device-enforcement:Z-0010-2025

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 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238

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.