ModerateClass IITerminated

FDA Devices recall · Reported June 8, 2016

CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1831-2016.

Q: Where was the recalled product distributed?

Distribution: US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA..

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.

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

Recall #: Z-1831-2016
Affected scope: 13,696,830 units
Initiated: April 22, 2016

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

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Smiths Medical Asd, Inc. recalled CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-… - a moderate-severity action.

CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-… was recalled by Smiths Medical Asd, Inc. in June 8, 2016. Reason: Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow…. Check the official notice for the remedy. Verify recall #Z-1831-2016 with the FDA Devices before acting.

The recall

Smiths Medical Asd, Inc. issued this moderate-severity FDA Devices recall-Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow….

Moderate
severity level: 13.7M units
affected scope: Class II
classification: June 8, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1831-2016 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 moderate 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 Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.

Reason for recall

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1831-2016
Date reported	June 8, 2016
Date initiated	April 22, 2016
Recalling firm	Smiths Medical Asd, Inc.
Firm location	Saint Paul, MN
Affected scope	13,696,830 units
Distribution	US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, M…

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

Scale of Impact

13,696,830 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-1831-2016) 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.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼

Why was this product recalled? ▼

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1831-2016.

Where was the recalled product distributed? ▼

Distribution: US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA..

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

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Similar severity · nearest report date

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This recall: FDA Devices, reported June 8, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026