[過去ﾛｸﾞ] 【天誅】犯罪逮捕事件を起こした医師・医者・病院その他医療施設1 [無断転載禁止]©2ch.net (1002ﾚｽ)
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280(1): 2018/01/08(月)11:04 ID:fr7NufCE(1/2) AAS
ジョンソン・エンド・ジョンソンでまた販売した欠陥製品の発表

【 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.
省7

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281: 2018/01/08(月)11:05 ID:fr7NufCE(2/2) AAS
>>280 の続き

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.

＜ソース＞
外部ﾘﾝｸ[htm]:www.fda.gov
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