Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
Date of publication: 02-01-2018
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). Źródło: https://www.fda.gov