Class I Recall: Fresh Frozen Plasma-LR 'Nisseki' 480 (PMDA Recall Notice)
クラスI回収 該当回収品目 新鮮凍結血漿-LR「日赤」480
Published: 2026-09-07 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-09-08
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted a safety update identifying Fresh Frozen Plasma-LR 'Nisseki' 480 as an item subject to a Class I recall. The item was published on 2026-09-07 under PMDA's safety and recall information services. Further details on the reason and scope of the recall are not provided in this metadata.
Business Impact
Organizations handling or administering this blood product may need to check whether affected lots are in their inventory. Healthcare providers could be affected if the recalled product is in use.
Recommended Action
Review the official PMDA recall notice at the provided source to confirm the affected product details, lot information, and any recommended handling steps.