The United States Food and Drug Administration recently announced the Class I recall of certain Smiths Medical Recalls CADD System Administration Sets and Cassette Reservoirs. The recalls were initiated due to the risk of serious injury or death. FDA Class I recalls is the most serious type of recall issued by the government agency. The […]
The United States Food and Drug Administration recently announced the Class I recall of certain Smiths Medical Recalls CADD System Administration Sets and Cassette Reservoirs. The recalls were initiated due to the risk of serious injury or death. FDA Class I recalls is the most serious type of recall issued by the government agency.
The recalled products, the CADD Ambulatory Infusion System Administration Sets and Cassette Reservoirs were distributed starting on June 15, 2018, until present and involved nearly 20,000,000 medical devices. This recall was initiated last month.
Smiths Medical’s CADD Ambulatory Infusion systems supply controlled amounts of medicines to patients in outpatient, hospital, and home environments. The affected CADD Medication Cassette Reservoirs and CADD Administration Sets are disposable and are designed for use with Smiths Medical’s CADD infusion pumps. These devices deliver drugs intravenously or via other paths of administration.
Smiths Medical initiated the recall of certain CADD Medication Cassette Reservoirs and CADD Administration Sets due to two potential problems that could result in injury or death:
Both of these issues can lead to delay of therapy, under-delivery of medication, or interruption of therapy and have the potential to cause severe injury or death. Smiths Medical has reported that they are aware of more than 1,500 adverse incidents, 14 injuries, and two deaths connected with the tubing occlusion issue, and more than 9,000 adverse incidents and 11 injuries associated with the false NDA alarm issue.
Patients who are treated with a recalled CADD infusion system with Medication Cassette Reservoirs or CADD Administration Sets could be affected by this recall. Health care professionals providing therapy using the CADD infusion system with Medication Cassette Reservoirs or CADD Administration Sets are also affected by this recall.
Smiths Medical sent an Urgent Medical Device Correction letter on December 9, 2022, to customers providing the following urgent recommendations:
For both recalls:
For the tubing occlusion issue:
For False “No Disposable Attached (NDA)” Alarms:
To report any adverse incident events or product complaints, call Smiths Medical Global Complaint Management through their website, smiths-medical.com. Healthcare professionals and patients should report any adverse reactions or quality issues they have experienced while using these devices to MedWatch.
If you or a loved one have been harmed, or if a loved one passed away due to this recalled medical device, you or your loved one could receive monetary compensation. The time is limited to make a product injury or wrongful death claim. So, do not delay and contact Parker Waichman LLP to receive a free consultation.
Parker Waichman LLP helps families recover financial compensation for harm caused by defective products. For your free consultation, contact our National Products Liability Law Firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).