FDA Device recall Z-0964-2023
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. C…
- 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 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. C… 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-0964-2023 |
| 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 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
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 21-7308-24, UDI/DI 30610586032374, Lot Numbers: 4053922 through 4334076; b) REF 21-7309-24, UDI/DI 30610586032…a) REF 21-7308-24, UDI/DI 30610586032374, Lot Numbers: 4053922 through 4334076; b) REF 21-7309-24, UDI/DI 30610586032381, Lot Numbers: 4062405 through 4334085; c) REF 21-7310-24, UDI/DI 30610586032398, Lot Numbers: 4062404 through 4330874 d) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; e) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870. |
|---|
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-0964-2023%22
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