【 FDA issues Class I recall for select J&J Sterilmed Agilis steerable introducer sheaths 】 JANUARY 3, 2018 （2018年1月3日）
The FDA yesterday issued a recall for Johnson & Johnson (NYSE:JNJ) subsidiary Sterilmed’s reprocessed Agilis steerable introducer sheaths over issues with possible air embolisms, labeling the recall as a Class I.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Sterilmed’s Agilis steerable introducer sheath is designed for the insertion and positioning of cardiovascular catheters in the heart, including the left side of the heart through the interarterial septum.
The devices are being recalled over issues with the incorporated hemostatic valve, designed to prevent blood flow back through the valve. The FDA noted that these valves may fail due to an improper seal of the sheath hub which could allow blood to leak back to the hub, resulting in the device’s cap falling off or a possible difference in pressure that could allow air into the circulatory system causing an air embolism.
The improper sealing occurs due to a lack of glue used to reattach the cap to the hub after reprocessing, while too much glue could block the sheath valve and make the device unusable. Results from the issues include serious health consequences for patients, including death, according to the FDA.
FDAはこれをクラスIのリコールとしています。これは最も重大なリコールです。 これらのデバイスを使用すると、重大なけがや死亡を引き起こす可能性があります。 The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death./