Skip to main content
High RiskFDAfda-Z-0061-2018STERILITY ISSUE

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...

Units Affected
11,170,535
Recall Date
September 25, 2017
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0061-2018.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0061-2018.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0061-2018.

Smiths Medical ASD Inc.

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDAFile a report at FDA

Smiths Medical Asd Inc. Recall FAQ

Smiths Medical Asd Inc. is the subject of a medical devices safety report: CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc.... The notice was published on September 25, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 11,170,535 units are potentially affected.