FDA Enforcement
Class II
Ongoing
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Recall: Z-0015-2025
·
Reported October 30, 2024
Enforcement
- Recall Number
- Z-0015-2025
- Event ID
- 95305
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 30, 2024
- Initiation Date
- June 26, 2024
- Classification Date
- October 18, 2024
- Address
- 6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States
Description
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
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 Info
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
Worldwide distribution.
Quantity
109563 units