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openFDA 器械召回·· 8 天前精选AI 评分45

Medline 多款血液与尿液采集套件因无菌涂抹器真菌污染被召回

Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catalog Number: DYNDH1694A; 6) DYNDH1695, Catalog Number: DYNDH1695; 7) DYNDH1708A, Catalog Number: DYNDH1708A; 8) DYNDH1714A, Catalog Number: DYNDH1714A; 9) DYNDH1723, Catalog Number: DYNDH1723; 10) DYNDH1740B, Catalog Number: DYNDH1740B; 11) DYNDH1741B, Catalog Number: DYNDH1741B; 12) DYNDH1771A, Catalog Number: DYNDH1771A; 13) DYNDH1908, Catalog Number: DYNDH1908; 14) DYNDH1940, Catalog Number: DYNDH1940; 15) DYNDH1988, Catalog Number: DYNDH1988; 16) DYNDH2002, Catalog Number: DYNDH2002; 17) DYNDH2017, Catalog Number: DYNDH2017. Blood and urine collection kits

AI 导读

Medline 召回多款血液和尿液采集套件(含 DYNDB3086D、DYNDB3100、DYNDH1619A 等 17 个目录号),原因是套件中部分批次的无菌涂抹器可能受真菌污染。该污染在特定环境条件下可滋生 Aspergillus penicillioides,用于皮肤准备产品时可能导致系统性感染、脓毒症、疾病甚至死亡。

推荐理由

召回信息点明了污染微生物种类与可能导致的系统性感染等后果,可供使用者核对涉事产品批号。

来源:openFDA 器械召回 · api.fda.gov