FDA designates Class 1 recalls for intraoperative positioning guidewires, infusion pumps, dialysate

Editor's Note

Centerline Biomedical’s recall of IOPS Guidewire ATW-2,  Zyno Medical’s recall of Z-800 series infusion pumps, and Nipro’s recall of MedicaLyte Liquid Bycarbonate Concentrate have been designated by the US Food and Drug Administration (FDA) as Class 1, the most serious designation indicating risk of severe injury or death. As  

The IOPS Guidewire ATW-2 is used with IOPS system to navigate through vasculature and place catheters. The coating on guidewires for lot 2404-2005 may delaminate during use, resulting in the risk of part of the coating being left inside the patient, FDA reports. As detailed in the June 16 announcement, the manufacturer recommends reviewing inventory and returning affected products for replacement. No injuries or deaths have been reported. 

The Zyno Medical recall specifically involves certain Z-800, Z-800F, Z-800W and Z-800WF models released to customers with software that had not undergone required verification and validation testing. “As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention,” FDA reports, noting that worst-case scenarios could range from incorrect dosage to blood clots and peripheral IV catheter failure. The June 13 announcement offers additional detail, including serial numbers of affected devices and instructions on discontinuing use and returning the products. No injuries or deaths have been reported.  

Nipro’s MedicaLyte Liquid Bycarbonate Concentrate— dialysate used hemodialysis systems—is being recalled due to tests that revealed bacterial dn fungal particles. Risks include treatment disruption, infection, sepsis, and death. One serious injury and no deaths have been reported so far. As detailed in FDA’s June 13 announcement, the product should not be used, devices in possession should be isolated, and recipients of distributed lots should be notified. The full report offers additional detail.