Smiths Medical’s warning pertains to specific models and lots of its 50 mL and 100 mL CADD medication cassette reservoirs. Certain reservoirs may exhibit a weakened weld joint between the medication bag and tubing. The company chalked this up to a production equipment malfunction.
This weakened weld joint could result in a medication leakage at or near the affected joint. Leakage could potentially result in delay or interruption of therapy, under-delivery of medication exposure to infectious or toxic agents or air embolus.
Smiths Medical reports one serious injury and zero deaths related to the issue. Due to the potential for serious adverse health consequences — such as permanent disability or death — the company recalled several lots for five different models of the cassette reservoir. Affected lots can be found here.
Customers in possession of affected devices should quarantine and discard any found affected products. Smiths Medical said it intends to provide credit to affected customers upon receipt of a completed response form to certify product destruction.
“Smiths Medical is committed to providing quality products and service to our customers,” the notice reads. “We apologize for any inconvenience this situation may cause.”
Smiths Medical’s business includes syringe and ambulatory infusion devices, vascular access and vital care products. ICU Medical acquired it for $2.35 billion in 2022.
The company has faced some significant challenges over the past few months, including:
- The closing of a New Hampshire plant, affecting 220 jobs.
- Warnings of an issue with Portex tracheotomy tubes.
- An FDA Class I recall — the most serious kind — for certain ventilator systems.
- An April 3 warning on CADD-Solis infusion pump software.
- A software recall affecting nearly 86,000 Medfusion infusion pump systems.
