Device product

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

Z-0015-2025

June 26, 2024

Class II

Product summary

Firm: Smiths Medical ASD Inc.
Event: Event 95305
Status: Ongoing
Classification: Class II
Quantity: 109563 units
Official record key: device-enforcement:Z-0015-2025

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: UID/DI NA, Lot/Serial Numbers: 3983315, 3971709, 3983316, 3983320, 3983329, 4013361, 4013363, 4013373, 4013377, 4013378, 4019427, 4019429, 4034028, 4037753, 4052410, 4040250, 4042843, 4048894, 4046846, 4052412, 4052413

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.