CriticalClass IOngoing

FDA Devices recall · Reported February 8, 2023

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 8, 2023. Severity: Critical. Recall number: Z-0962-2023.

Q: Where was the recalled product distributed?

Distribution: 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.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-0962-2023
Affected scope: 1616714 units
Initiated: December 9, 2022

Compiled from official public sources by the publisher. · Updated September 2026

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Smiths Medical Asd Inc. recalled CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 - a critical-severity action.

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 was recalled by Smiths Medical Asd Inc. in February 8, 2023. Reason: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdeliv…. Check the official notice for the remedy. Verify recall #Z-0962-2023 with the FDA Devices before acting.

The recall

Smiths Medical Asd Inc. issued this critical-severity FDA Devices recall-There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdeliv….

Critical
severity level: 1.6M units
affected scope: Class I
classification: February 8, 2023
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0962-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) places it in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Ongoing
Recall number	Z-0962-2023
Date reported	February 8, 2023
Date initiated	December 9, 2022
Recalling firm	Smiths Medical Asd Inc.
Firm location	Minneapolis, MN
Affected scope	1616714 units
Distribution	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

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1616714 units units affected - million-unit bracket.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0962-2023) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24. Recalled by Smiths Medical Asd Inc.. Units affected: 1616714 units.

Why was this product 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 agency issued this recall? ▼

This recall was issued by the FDA Devices on February 8, 2023. Severity: Critical. Recall number: Z-0962-2023.

Where was the recalled product distributed? ▼

Distribution: 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.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 8, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026