FDA警示:英特格拉生命科学发现Medihoney伤口与烧伤产品包装缺陷,可能导致无菌屏障破坏

美股速递
Jan 23

美国食品药品监督管理局(FDA)发布公告称,医疗设备制造商英特格拉生命科学公司在其Medihoney伤口护理与烧伤治疗产品线中发现包装工艺存在缺陷。经调查确认,该缺陷可能致使产品无菌保护层受损,存在微生物污染风险。

目前企业已启动针对性纠正措施,包括加强包装质检流程与供应链追溯体系。FDA建议医疗机构立即检查库存产品包装完整性,若发现胀包、破损或密封异常应立即停用。

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