CLASS I ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
CADD Administration Set, List Numbers: a) recalled by Smiths Medical ASD
Smiths Medical ASD is recalling CADD Administration Set, List Numbers: a), distributed nationwide in the US. The recall was initiated on 9 Dec 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0962-2023
- FDA event ID
- 91392
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Dec 2022
- FDA classified
- 30 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 9 Dec 2022 | Recall initiated by company | |
| 30 Jan 2023 | Classified by FDA | +52 days |
| 8 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Where it was distributed
Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
Questions about this recall
Is CADD Administration Set, List Numbers: a) recalled?
Yes. Smiths Medical ASD recalled CADD Administration Set, List Numbers: a) on 9 Dec 2022. The recall is Class I and its status is Ongoing. Recall number Z-0962-2023.
Why was it recalled?
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
Which lots are affected?
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;
Where was it sold?
Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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