RecallRadar

FDA Device recall Z-0962-2023

CADD Administration Set, List Numbers: a) REF 21-7346-24

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

AgencyFDA Device
Recall numberZ-0962-2023
ClassificationClass I
Statusongoing
Initiated2022-12-09
Published2023-02-08
Last updated2026-09-13 11:56 UTC
CompanySmiths Medical Asd
DistributionUS

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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