Generic Name: (1)-(3) Antimicrobial Urinary Catheters, (4) Short-term Urinary Foley Catheters — Brand Name: (1) Bird Silver Tsc Tray — (2) Bird Silver Brillic Foley Tray — (3) Bird I.c. Silver Foley Tray B — (4) Bird I.c. Foley Tray B
- Recalling firm
- Name of Manufacturer/Distributor: Medicon Co., Ltd. — Address of Manufacturer/Distributor: 1-13-22 Sonezaki Shinchi, Kita-ku, Osaka City, Osaka Prefecture — Type of License: Class I Medical Device...
- Product
- Lot: 販売名(1) バードシルバーＴＳＣトレイ カタログ番号：5530014LWS ロット番号：MYGU1735 / MYGX1491 / MYGY1171 / MYGZ2024 / MYHZ3455 / MYJQ2791 / MYJU0946 カタログ番号：5550014LWS ロット番号：MYHX3641 カタログ番号：556014LRWS ロット番号：MYGV0715 / MYGX3601 / MYGY1172 / MYHY4086 / MYJP1023 / MYJS1141 販売名(2) バードシルバールブリシルフォーリートレイ カタログ番号：29000J14S ロット番号：MYGU2977 / MYGX3235 / MYGY0974 / MYHN3064 / MYHT2650 / MYJW1903 / MYJY0937 / MYJY1249 カタログ番号：29030J14S ロット番号：MYGV2380 / MYGW1608 / MYGY0975 / MYHY0068 / MYJU0773 カタログ番号：6610J14CS ロット番号：MYGQ1202 / MYGQ5486 / MYGV0716 カタログ番号：66300J16S ロット番号：MYGS1654 販売名(3) バードＩ．Ｃ．シルバーフォーリートレイＢ カタログ番号：7730014LS...
- Reason
- We have received a report from the overseas manufacturer indicating that some of the Skin Prep Pads (a pre-treatment agent used prior to applying the StatLock device), which are components of this product, had expired. Following an internal investigation, we confirmed that the affected products had been shipped to the market, and have therefore 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/6c43afc5-1111-40d7-8213-afc64356e5da