FDA Device recall Z-0962-2023
CADD Administration Set, List Numbers: a) REF 21-7346-24
- FDA Device
- Class I
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class I recall of CADD Administration Set, List Numbers: a) REF 21-7346-24 by Smiths Medical Asd, citing there are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (ND….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0962-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-12-09 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Reason
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
Identifiers
| code_info | a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 350195171…a) REF 21-7346-24: UDI/DI 35019517161957; Lot Numbers: 3776356 through 4320785; b) REF 21-7363-24: UDI/DI 3501951716196; Lot Numbers: 3773412 through 4334343; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0962-2023%22
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