The FDA today said it is designating a recall of CME America BodyGuard microset infusion sets as Class I — it’s most serious level — after complaints of under-infusion related to the sets.
CME America, a subsidiary of Becton Dickinson (NYSE:BDX), initiated the U.S. recall of the sets (catalog number A120-003XYVA) on Sept. 6, 2019, recalling 91,500 devices that had been distributed between Oct. 6, 2017, and July 15, 2019. All lots of the affected catalog number were recalled.
The company found that the specific infusion sets that have an extended section of tubing that runs longer than standard lengths prohibitively restrict medication flow to the pumping chamber of the infusion pump. If this happens, it could result in under-infusion, the patient may not receive the appropriate treatment and there could be serious adverse health consequences, including death.
So far, CME America has received three complaints of under-infusion, with the issue found during pump set-up testing prior to its use on patients. No injuries or deaths have been reported.
In September, the company told customers to discard all affected infusion sets, ensure that all users are aware of the recall and report adverse events to the FDA’s MedWatch adverse event reporting program.