FDA Device recall Z-0966-2023
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) RE…
- 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: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) RE… 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-0966-2023 |
| 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: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. 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 | 1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 3061058602721…1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7308-24, UDI/DI 30610586032374, Lot numbers: 4053922 through 4334076; 5) REF 21-7309-24, UDI/DU 30610586032381, Lot numbers: 4062405 though 4334085; 6) REF 21-7310-24, UDI/DU 30610586032398, Lot numbers: 4062404 through 4330874; 7) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 8) REF 21-7323-24, UDI/DI 30610586039618, Lot numbers: 3776373 through 4334325; 9) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 10) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7346-24, UDI/DI 35019517161957, Lot numbers: 3776356 through 4320785; 13) REF 21-734 |
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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-0966-2023%22
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