Medline 多款脊柱与开颅手术器械包因神经海绵内毒素风险被召回
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, Catalog Number: DYNJ54479C; 13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815; 14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C; 15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C; 16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C; 17) SPINAL PACK-LF, Catalog Number: DYNJ67543B; 18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A; 19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098; 20) SPINE, Ca
Medline 召回多款便利器械包,包括 ANTERIOR SPINE PACK、CRANIOTOMY PACK、LAMINECTOMY PACK 等 20 余个目录号产品,原因是包内神经海绵的内毒素水平可能存在意外波动。openFDA 器械召回信息显示,内毒素水平可能升高,或带来需要医疗干预的健康风险,如神经血管不良事件、发热反应、局部一过性炎症、低血压或恶心。
召回涉及多款脊柱与开颅手术器械包,因神经海绵内毒素水平可能异常,读者可了解具体风险类型与涉及产品范围。
来源:openFDA 器械召回 · api.fda.gov