Fresenius Kabi has recalled one lot of its Ivenix large volume pump primary administration sets after identifying a manufacturing defect that could cause uncontrolled medication flow.
The FDA has identified the type of recall as serious, with a risk of medication overdose and death when continuing to use the product, according to a Sept. 16 news release from the agency.
The affected product is the Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site. The manufacturer sent affected customers a letter recommending the destruction or return of the affected product and that replacements be requested.
There have been two reported injuries, the release said.
Editor's note: This article was updated Sept. 18 at 2:45 p.m. CT.