Dive Brief:
- Zyno Medical has recalled infusion pumps that shipped with software that had not undergone verification and validation testing, the Food and Drug Administration said Monday.
- The company released the Z-800 pumps with incorrect software versions. The software created a risk of incorrect air-in-line detection and audio alarms that could cause serious harm.
- Zyno has not reported any serious injuries or deaths. The recall, which the FDA assigned to Class I, started eight months after Zyno removed Z-800 pumps from use over another software issue.
Dive Insight:
Healthcare professionals use Zyno’s Z-800, Z-800F, Z-800W and Z-800WF pumps to provide intravenous infusions of parenteral fluids, blood and blood products. The company first secured 510(k) clearance for a Z-800 pump in 2007.
In May, Zyno wrote to customers about a problem with the pumps. The company asked customers to stop using certain infusion pumps and wait for someone from its partner, infusion pump distributor Intuvie, to contact them about exchanging devices. The FDA said the Zyno recall affects 613 units across the U.S.
Zyno has recalled its Z-800 devices because of incorrect, unvalidated software that can cause unexpected performance problems. The problems include issues with essential functions and risk measures such as air-in-line detection, alarm volume and reverse flow prevention. Because of the issues, the pumps could deliver too much or too little, infuse air into the vein or lower the keep-vein-open rate.
Lowering the keep-vein-open rate could cause a blood clot to form at one end of the catheter, the FDA said. The clot could lead to peripheral intravenous catheter failure. Such risks led the FDA to conclude the pumps could cause serious injury or death.
Zyno recalled Z-800 pumps linked to two reported injuries in September. The recall was triggered by a defect in the air-in-line software algorithm that could allow an air bubble to be infused into the venous system. The Class I recall in September was one of several notices posted by the FDA about Z-800 pumps last year. The other Z-800 notices in 2024 were lower-risk Class II or Class III recalls.
