Generic Name: Non-cough-inducing Ventilation Endotracheal Tube — Trade Name: (1) Portex Endotracheal Tube (ivory) — (2) Portex Endotracheal Tube (siliconized)

Recalling firm: Name of Manufacturer and Distributor: ICU Medical Japan Co., Ltd. — Address of Manufacturer and Distributor: Aoyama Yasuda Building, 7-1-1 Akasaka, Minato-ku, Tokyo — License Type: Class I Medical...
Product: Lot: 販売名：PORTEX・気管内チューブ（アイボリー）製品品番：100/105/025 ロット番号：4345413 出荷数量：200個出荷時期：令和6年4月23日〜令和6年10月17日製品品番：100/105/030 ロット番号：3990354、4011059、4062709、4077446、4091972、4121698、4166633、4192137、4214842、 4247557、4282245、4337268 出荷数量：1185個出荷時期：令和3年3月2日〜令和6年11月18日製品品番：100/105/035 ロット番号：4007482、4023465、4059423、4121695、4150613、4190222、4222896、4269334、4308452、 4347847、4370803、6010588 出荷数量：1404個出荷時期：令和3年2月25日〜令和6年11月13日販売名：PORTEX・気管内チューブ（シリコナイズド）製品品番：100/111/020 ロット番号：4018131、4029076、4053374、4085815、4110000、4112845、4135636、4187114、4206539、...
Reason: We have received notification from our overseas manufacturer regarding the PORTEX Endotracheal Tubes (Ivory) and PORTEX Endotracheal Tubes (Siliconized) that we manufacture and sell. It has been determined that, in specific lots of certain sizes of these products, the inner diameter of the endotracheal tube may be smaller than specified. Consequently, the manufacturer has informed us that it will conduct a voluntary recall of the affected lots. Upon receiving this notification, we have decided to voluntarily recall the affected products, taking into consideration product quality, efficacy,...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/7841c622-f413-465d-abbf-f2c56f4ea8cf