Medical technology firm GE HealthCare has moved to reassure customers that its iodinated contrast supply remains stable following a World Health Organization alert over a quality defect identified at its manufacturing facility in Cork, Ireland.

According to Radiology Business, the WHO issued a Medical Product Alert on 7 May for multiple batches of Accupaque, Omnipaque and Visipaque contrast solutions supplied in 100ml polypropylene containers produced at the Cork site. The alert was triggered after Ireland's Health Products Regulatory Authority notified the WHO of a Class 1 quality defect involving the possibility of metallic particulate matter adhered to or embedded within the inner surface of the polypropylene bottles.

The defect was not with the contrast solutions themselves but with their packaging. If injected, particulate matter present in the solution could cause life-threatening embolic events. No adverse events have been reported in connection with the affected batches.

GE HealthCare identified at least one instance of free metallic particulate in a finished product before alerting regulatory authorities and activating a second bottle supplier to maintain continuity of supply.

"Patient safety is our top priority," a GE HealthCare spokesperson said. "When GE HealthCare became aware of a manufacturing issue with a bottle supplier, which is now resolved, we acted swiftly to leverage our second supplier and report it to regulatory authorities. In most cases, we are meeting customer demand with alternative stock keeping units which are not impacted."

The company said the disruption to its supply chain was short-lived and that normal operations have resumed at the Cork facility.

Read the full coverage for further detail on the WHO alert and GE HealthCare's supply response.