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May 09, 2023

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under

The FDA has identified this as a Class I recall, the most serious type of

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

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.

Smiths Medical is recalling certain CADD Administration Sets and Medication Cassette Reservoirs for two potential issues:

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.

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.

On December 9, 2022, Smiths Medical sent customers an Urgent Medical Device Correction letter. The letter recommended the following actions:

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.

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.

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.

To report adverse events or product complaints, you can call Smiths Medical Global Complaint Management at 1-(866)-216-8806, or email [email protected]

For additional information or technical assistance, you can contact Smith Medical's Technical Assistance at 1-(800)-258-5361.

Medical Device Recall Database entries:

Class 1 Device Recall CADD Disposables

Class 1 Device Recall CADD Disposables

Class 1 Device Recall CADD Disposables

Class 1 Device Recall CADD Disposables

Class 1 Device Recall CADD Disposables

Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD Infusion System Infusion Sets for Use with CADD Pumps

Smiths Medical Customer Notification Letter

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.

02/02/2023