CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report

CADD" Medication Cassette Reservoir recalled by Smiths Medical ASD

Smiths Medical ASD is recalling CADD" Medication Cassette Reservoir, distributed nationwide in the US. The recall was initiated on 2 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324

Quantity recalled48,208 (17,040 US, 31,168 OUS).

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-1286-2015
FDA event ID: 70402
Recalling firm: Smiths Medical ASD, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 2 Feb 2015
FDA classified: 17 Mar 2015
Reported: 25 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

2 Feb 2015	Recall initiated by company
17 Mar 2015	Classified by FDA	+43 days
25 Mar 2015	Published in enforcement report	+8 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 has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

Where it was distributed

Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, Denmark, Spain. Finland, France, United Kingdom (GB) Hungary, Indonesia, Ireland, Italy, Netherlands, Portugal, Sweden, Singapore and South Africa.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Illinois Massachusetts Maryland Minnesota Missouri Mississippi North Carolina Nebraska New Hampshire New Jersey

Questions about this recall

Why was it recalled?

Which lots are affected?

21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324

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.

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