【 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.
The federal watchdog said that patients with lower body mass index may be more at risk if blood loss occurs, and smaller patients and patients with pre-existing decreased pulmonary reserves may be extra susceptible to air embolisms.
The federal watchdog said that the recall affects 112 devices manufactured and distributed between January 1, 2017 and May 5, 2017, with product code PNE and model numbers STJ408309, STJ408310, STJG408324. All product lots are indicated in the recall, according to the FDA release.
Sterlimed instructed users of the device to examine inventory for affected devices and return unused products to the company.
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./
こういった自社製品の不都合な情報って社内では共有されないよね。 外回りの営業職の士気が下がるから黙ってろって内勤へシニアマネージャーなんかは圧力かけるから。 逆を言えばJ&Jの営業職は会社からも「北朝鮮みたいに都合の良い情報」しか教えてもらえない。 0029名無しさん@お腹いっぱい。2018/01/08(月) 13:01:38.00>>28 現時点でタケダとアステラスってどちらが待遇がいいの? 0030名無しさん@お腹いっぱい。2018/01/08(月) 13:02:26.43 バランス的には、アステラスっぽいけどね。 0031名無しさん@お腹いっぱい。2018/01/21(日) 11:01:05.51 名スレあげ 0032名無しさん@お腹いっぱい。2018/01/24(水) 23:09:01.18 よいスレ 0033名無しさん@お腹いっぱい。2018/01/25(木) 00:18:21.56 女だけど外で犬飼ってるんだけど、寒そうで可哀想。なにか暖かくしてあげる方法ない? [542286535] https://leia.5ch.net/test/read.cgi/poverty/1516802813/0034名無しさん@お腹いっぱい。2018/01/25(木) 00:46:24.16 武田とトヨタ 0035名無しさん@お腹いっぱい。2018/01/27(土) 14:36:05.90 ageとくか 0036名無しさん@お腹いっぱい。2018/02/06(火) 23:24:24.63 名スレですね 0037名無しさん@お腹いっぱい。2018/02/07(水) 09:01:18.37 武田君と山口県 0038名無しさん@お腹いっぱい。2018/02/12(月) 06:36:17.86 あげやな 0039名無しさん@お腹いっぱい。2018/02/12(月) 06:40:39.20 Come on come on come on come on Come on is such a joy Come on is such a joy Come on lets take it easy Come on lets take it easy Take it easy take it easy Everybody's got something to hide except for me and my monkey.
The deeper you go the higher you fly The higher you fly the deeper you go So come on come on Come on is such a joy Come on is such a joy Come on lets make it easy Come on lets make it easy. Take it easy take it easy Everybody's got something to hide except for me and my monkey.
Your inside is out and your outside is in Your outside is in and your inside is out So come on come on
Come on is such a joy Come on is such a joy Come on lets make it easy Come on lets make it easy Make it easy make it easy Everybody's got something to hide except for me and my monkey. 0040名無しさん@お腹いっぱい。2018/02/21(水) 20:14:57.63 良スレage 0041名無しさん@お腹いっぱい。2018/02/21(水) 22:51:42.20 武田を照らす TAKETERASU 誕生 0042名無しさん@お腹いっぱい。2018/03/07(水) 21:26:25.57 頭おかしい朝鮮人と思われるMRが発狂連投中でわろた 尚、卸MSに虐められ過ぎて狂った模様wwwww