CLASS II Device recall · Reported 8 Nov 2017 · FDA Enforcement Report

CADD(TM) Medication Cassette Reservoir with clamp recalled

Smiths Medical ASD is recalling CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper, distributed nationwide in the US. The recall was initiated on 25 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled11170535 units

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-0061-2018
FDA event ID: 78255
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 25 Sep 2017
FDA classified: 1 Nov 2017
Reported: 8 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

25 Sep 2017	Recall initiated by company
1 Nov 2017	Classified by FDA	+37 days
8 Nov 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Product as listed by the FDA

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

Where it was distributed

Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Which lots are affected?

All lot numbers

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 78255

Reported	Class	Recall	Company	Reason	Where
8 Nov 2017	CLASS II	CADD(TM) Medication Cassette Reservoir with clamp and female Luer recalled	Smiths Medical ASD	Other	Nationwide
8 Nov 2017	CLASS II	CADD(TM) Yellow Medication Cassette Reservoir with clamp recalled	Smiths Medical ASD	Other	Nationwide

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