Generic Name: Anesthesia Circuit Set — Brand Name: Dräger Catheter Mount Ergostar
- Recalling firm
- Name of Manufacturer/Distributor: Dräger Japan Co., Ltd. — Address of Manufacturer/Distributor: Meguro Tokyu Building, 2-13-17 Kamiosaki, Shinagawa-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: （１）製品名：ドレーゲルカテーテルマウント ErgoStar CM40 製品番号：MP01840 数量：28300本 出荷時期：2023年3月22日〜2025年9月29日(*) 対象ロット番号：6256.2903.14, 6257.1903.14, 6423.2004.14, 6431.2004.14, 6474.1904.13, 6527.2805.14, 6746.3105.14, 7077.1208.14, 7078.3107.14, 7168.1509.13, 7348.2708.14, 7354.2708.14, 7506.1710.13, 75 97.0410.14, 7681.2011.13, 7682.1811.13, 7762.2110.14, 7763.2110.14, 7827.0412.13, 7945.0712.13, 7971 .0302.14, 7972.0302.14, 8145.0912.14, 8146.1012.14, 8372.1501.15, 8373.1401.15, 8374.1101.15, 8375.1 001.15, 8550.2901.15 （２）製品名：ドレーゲルカテーテルマウント ErgoStar CM45 製品番号：MP01845 数量：43000本...
- Reason
- During post-market surveillance activities conducted by the overseas manufacturer, cases were reported in which cracks developed in the tubing of the Dräger Catheter Mount ErgoStar (hereinafter referred to as “the product”). Consequently, we have decided to provide information to the medical institutions to which the product was shipped and to recall the product.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/763ccf4d-c49e-4464-afd6-26ba5fccf686