Generic Name: Antimicrobial Urinary Catheter — Brand Names: (1) Bardex Silver Brillil Temperature Sensor Catheter — (2) Bard Silver Brillil Foretray
- Recalling firm
- Name of Manufacturer/Distributor: Medicon Co., Ltd. — Address of Manufacturer/Distributor: 1-13-22 Sonezaki Shinchi, Kita-ku, Osaka City, Osaka Prefecture — License Type: Class I Medical Device...
- Product
- Lot: 販売名（１） カタログ番号：119314 ロット番号：NGJS3588 / NGJW2499 / NGJX0215 販売名（２） カタログ番号：29000J14 ロット番号：MYJP0751 / MYJQ0070 / MYJQ4022 / MYJR1984 / MYJR3026 / MYJS3597 / MYJS4679 / MYJS6278 / MYJT3764 / MYJT3765 / MYJT3766 / MYJV4359 / MYJW1900 / MYJX0683 / MYJX0686 / MYJX2833 / MYJY6197 / M YJZ0962 / MYJY1245 / MYJY1242 / MYJY1248 カタログ番号：29000J14S ロット番号：MYJW1903 / MYJY0937 / MYJY1249 カタログ番号：29030J14 ロット番号：MYJN2580 / MYJP2012 / MYJP2013 / MYJP4407 / MYJQ0071 / MYJQ0072 / MYJQ0073 / MYJQ4023 / MYJQ4024 / MYJR3027 / MYJR3059 / MYJR3083 / MYJS1893 / MYJS1894 / MYJS1895 / MYJS3599 / MYJS6279 / M YJT1017 /...
- Reason
- We have received reports from domestic medical institutions that urine cannot be observed flowing from the drainage lumen after catheter placement with this product. Following an investigation by the overseas manufacturer, an issue was identified during the manufacturing of a specific lot that causes blockage of the drainage lumen; therefore, we have decided to conduct a voluntary recall.
- 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/f12b4238-2bb5-407e-9b85-1f0956cc3a39