The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The recalled devices are designed for use in hospital pharmacies to filter bacteria and other microscopic matter during the preparation of water-based solutions used for IV administration sets. The filter is designed to attach to Baxter’s standard pharmacy pump tube.
Baxter said it identified potential particulate matter and the “potential absence of filter membrane layers in the filter set,” both of which could contaminate the solution and result in blood stream infections. Infections from particulate matter and poor filtering can cause fever, septic shock, multiple organ dysfunction and other serious adverse effects, including death, the company said.
All unexpired lots under product code H93835 are affected by the recall, which includes approximately 130,100 units distributed nationwide, Baxter said. The recalled devices were manufactured between June 27, 2013, and June 27, 2016, and distributed between August 12, 2013, and June 20, 2016, according to the FDA.
Customers with the devices were notified in late August, Baxter said, and urged to contact the company to arrange for the return of any affected product.
In early September, the FDA released a notice warning of issues with Baxter’s Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occurred shortly after carotid endarterectomy procedures.