The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: CADD infusion system Administration Sets and Cassette Reservoirs
- Product Models: See Medical Device Recall Database entries
- Distribution Dates: June 15, 2018 to present
- Devices Recalled in the U.S.: 19,792,933
- Date Initiated by Firm: December 9, 2022
Device Use
CADD ambulatory infusion systems deliver controlled amounts of medications to patients in hospital, outpatient, and home settings. The CADD Administration Sets and CADD Medication Cassette Reservoirs are disposable and intended for use with CADD infusion pumps. They deliver the medication into a patient’s vein or through other cleared routes of administration.
Reason for Recall
Smiths Medical is recalling certain CADD Administration Sets and Medication Cassette Reservoirs for two potential issues:
- Tubing occlusion prevents delivery or causes under-delivery of medication. Manufacturing variations may cause the green CADD Flow Stop arm to compress and partially block (occlude) the tubing before clinical use. If the occlusion does not resolve when an affected reservoir or administration set is connected to the pump, the pump may not detect the occlusion, resulting in under-delivery or non-delivery of medication, though the pump will display that the infusion is running properly.
- False “No Disposable Attached (NDA)” alarm prevents pump use. Manufacturing variations on certain CADD Medication Cassette Reservoirs with Flow Stop may interfere with the pump detecting a properly attached CADD cassette. The pump will give an audible warning. If the audible warning is not resolved within two minutes, an NDA alarm will occur. The user must clear the alarm and resolve the cause of the NDA event before using the pump, resulting in the delay or interruption of therapy.
Either of these recall issues can cause delay of therapy, interruption of therapy, or under-delivery of medication, which all have the potential to cause serious patient harm or death.
Smiths Medical reports there have been 1,571 incidents, 14 injuries and 2 deaths related to the tubing occlusion issue and 9,101 incidents, 11 injuries and no deaths related to the false NDA alarm issue.
Who May be Affected
People who are treated using the CADD infusion system with CADD Administration Sets or Medication Cassette Reservoirs.
Health care personnel and caregivers providing care using the CADD infusion system with CADD Administration Sets or Medication Cassette Reservoirs.
Distributors of CADD Administration Sets or Medication Cassette Reservoirs.
What to Do
On December 9, 2022, Smiths Medical sent customers an Urgent Medical Device Correction letter. The letter recommended the following actions:
For both recall issues:
Use of alternative CADD infusion sets is recommended for life sustaining medications. Contact Smiths Medical customer service at 1-800-258-5361 for information on obtaining alternate CADD infusion sets.
Issue 1: Tubing Occlusion
Actions for Pharmacists
- Immediately identify affected products in your possession and ensure these products are separated and labeled as affected by this recall to avoid use for life sustaining medications.
- Pharmacists experiencing difficulty filling the cassettes of affected products should consider changing to a new infusion set and contact Smiths Medical Global Complaint Management to report the event.
Actions for Clinicians and Patients
- Be aware that when using products affected by this recall with a CADD pump, the medication may appear to be infusing normally, but may not be infusing at all or may be under-infusing, and the pump will not alarm.
- Clinicians can contact specialty pharmacies to discuss availability of alternative CADD infusion sets for life sustaining medications. Depending on availability and specific patient situations, clinicians may consider switching patients to an alternative pump.
- Always prime the set using the pump and watch the fluid flow closely during this process. If the fluid doesn’t flow properly or takes an abnormally long time to prime, or if the pump displays a higher than expected priming volume, replace the reservoir or set. The priming volume is listed on the packaging for each administration set.
- If medication remains in the reservoir at the completion of the infusion, contact a clinician and Smiths Medical Global Complaint Management to report the event.
- Clinicians should share this information with homecare patients and educate them to prime the set using the pump as mentioned above.
Issue 2: False "No Disposable Attached (NDA)" Alarms
Actions for Pharmacists
Immediately identify affected products in your possession and ensure these products are separated and labeled as affected by this recall to avoid use for life sustaining medications.
Actions for Clinicians and Patients
Be aware that the pump may not adequately detect the cassette before or during an infusion due to this issue, and an alarm will be triggered.
If a pump displays an NDA alarm, the user can attempt to resolve the alarm by repositioning the CADD Medication Cassette Reservoir while connected to the pump, repositioning the reservoir by disconnecting from the pump and reattaching it to the pump, or replacing the reservoir.
Alternatively, the user can remove the reservoir from the pump and push the plastic ridge towards the arch on the reservoir.
If the user cannot resolve the NDA alarm, replace the cassette reservoir, though the issues may recur if that product is also affected by this recall.
Clinicians should contact the pharmacy to discuss availability of alternative CADD infusion sets for patients receiving life-saving medications. Depending on availability and specific patient situations, clinicians may consider switching patients to an alternative pump.
Clinicians should share this information with homecare patients and educate them about the recommended actions.
Contact Information
To report adverse events or product complaints, you can call Smiths Medical Global Complaint Management at 1-(866)-216-8806, or email globalcomplaints@smiths-medical.com
For additional information or technical assistance, you can contact Smith Medical’s Technical Assistance at 1-(800)-258-5361.
Additional Resources:
Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD Infusion System Infusion Sets for Use with CADD Pumps
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
