FDA Device recall Z-0016-2025
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0016-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-26 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
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.
Identifiers
| code_info | UDI/DI NA, Lot/Serial Numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, 4052407 |
|---|
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-0016-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.