Generic Name: Catheter For Central Circulatory System Angiography — Trade Name: Technowood Softnav Catheter
- Recalling firm
- Name of Manufacturer/Distributor: Technowood Co., Ltd. — Address of Manufacturer/Distributor: 4-30-19 Kohoku, Adachi-ku, Tokyo — License Type: Class I Medical Device Manufacturer/Distributor —...
- Product
- Lot: カタログ番号：H710-FL4011 ロット番号：S24G1G109A, S24K1K109A, S25A1A110A 対象数量：15 本 カタログ番号：H710-FL4012 ロット番号：S24D1C112A, S24E1D112A, S24G1G113A, S24G1G117A, S24H1H107A, S24I1I106A, S24I1I108A 対象数量：435 本 カタログ番号：H710-FL4013 ロット番号：S24G1G104A, S24G1G114A, S24L1L107A, S24L1L112A 対象数量：20 本 カタログ番号：H710-FL4060 ロット番号：S24D1D107A, S24D1D108A, S24G1G113A, S24G1G119A, S24H1H107A, S24H1H113A, S24I1I106A, S24I 1I107A, S24J1J116A, S24K1K102A, S24K1K116A, S24L1L105A 対象数量：1,390 本 カタログ番号：H710-FL4122 ロット番号：S24E1E101A, S24F1F111A, S24G1G105A, S24G1G111A, S24H1H108A, S24K1K102A, S24K1K114A, S24L 1L106A, S24L1L110A,...
- Reason
- We have discovered that holes may form in the transparent film (a laminated film of polyethylene and PET) used for the primary packaging of some of our products, which could compromise sterility. Additionally, we have discovered that damage to the Tyvek paper used for the primary packaging could also compromise sterility. Therefore, we have decided to initiate 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/faac3bd5-3d5c-4fde-9f63-3ca87206ad91