Generic Name: Single-use Incision Device — Brand Name: Da Vinci Sp Access Port Kit
- Recalling firm
- Name of Manufacturer and Distributor: Intuitive Surgical LLC — Address of Manufacturer and Distributor: Ark Mori Building, 1-12-32 Akasaka, Minato-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 製品番号 ：430073（SP アクセスポートキット Small 2.7cm-4cm） 430075（SP アクセスポートキット Large 2.7cm-7cm） 出荷時期 ：令和6年4月4日〜令和7年11月5日 出荷数量 ：695箱(本製品は1箱6個入り) 対象ロット： (430073) K10250305 K10250424 K10250629 K10250710 K11250113 U10241115 U10250102 U10250108 U10250210 U10250318 U10250325 U10250331 U11241121 U11250123 U11250404 U11250425 U80231207 U80240118 U80240627 U80240711 U80240806 U80240905 U80241025 U81231219 U81240411 U81240617 U81240627 U81240905 (430075) K10250313 K10250327 K10250403 K10250515 K10250522 K10250529 K10250701 K10250702 K10250710 K10250723 K11250529 U10241101 U10241107 U10241217 U10250102...
- Reason
- Cracks have been detected in the plastic sterilization trays for this product held by our manufacturer. Our investigation confirmed that the thickness of the sterilization trays may be locally reduced in some cases, which could lead to cracking. Since we cannot rule out the possibility that severe cracks may compromise the sterility of the contents inside the trays, we have decided to voluntarily recall the affected lots of this 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/6d09a338-5422-43a2-abce-d8b36f5b9a74