Generic Name: Fresh Frozen Human Plasma Trade Name: Fresh Frozen Plasma-lr "japanese Red Cross" 480
- Recalling firm
- Name of Manufacturer/Distributor: Japanese Red Cross Society Address of Manufacturer/Distributor: Japanese Red Cross Society Annex, 1-2-1 Shibakoen, Minato-ku, Tokyo Type of License: Class I...
- Product
- Lot: 対象ロット： １２‐０６３０‐５６６５ 数量 ： ４８０ｍＬ １本 出荷時期 ： 令和７年５月３１日. Use: 血液凝固因子の補充 （１）複合性凝固障害で、出血、出血傾向のある患者又は手術を行う患者 （２）血液凝固因子の減少症又は欠乏症における出血時で、特定の血液凝固因子製剤がないか又は 血液凝固因子が特定できない場合. Health hazards: 当該血液製剤は、患者に使用されていないため、健康被害はありません。
- Reason
- In accordance with the procedures for handling post-donation information, we investigated a blood donor who tested positive for an infectious disease. Since the blood products derived from the donated blood had not yet been used, we decided to retrieve and recall those blood products from medical institutions.
- Classification
- Class I
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-02-02
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/4f34a976-b769-4fea-86d1-7641803cff28