Generic Name: Bronchial Tube For Ventilation — Brand Name: Parker Bronchial Tube
Parker Bronchial Tubes (product number I-PSTDL-37, lot 2503DL0604D) shipped between June 5 and July 9, 2025, are being recalled because some tubes were labeled with incorrect size markings. These double-lumen tubes are used during surgery to deliver anesthesia and manage ventilation, and using the wrong size could potentially compress or damage the windpipe or airways. No injuries have been reported so far, and healthcare providers can typically identify and correct size issues during use.
- Recalling firm
- Name of Manufacturer and Distributor: MC Medical Co., Ltd. — Address of Manufacturer and Distributor: Trade Pier Yodoyabashi, 2-5-8 Imabashi, Chuo-ku, Osaka City, Osaka Prefecture — Type of...
- Product
- Lot: 製品番号：I-PSTDL-37 ロット：2503DL0604D 数量：756本 出荷時期：2025年6月5日〜2025年7月9日. Use: 本品は、吸入麻酔薬の投与および換気のため、口腔から気管内に挿入されるダブルルーメンのチューブである。 必要に応じ、片側の肺への換気を制限する。. Health hazards: 誤ったサイズの製品を使用した場合、気管を圧迫する、或いは気管および気管支を傷つける可能性があります が、医療従事者の管理下において、適切な処置を行えることから重篤な健康被害のおそれはまず考えられませ ん。なお、現在までに当該事象に伴う健康被害の報告は受けておりません。
- Reason
- We have decided to conduct a voluntary recall after being informed by the shipping destination that products with labels bearing the legal markings for a different size were shipped as part of the affected lot.
- 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/b7cada67-e0f4-46bc-af40-1afba015301d