Generic Name: Emergency Indwelling Blood Access Catheter Trade Name: Centrosflow
- Recalling firm
- Location of manufacturer and distributor: Shinjuku Nomura Building, 1-26-2, Nishi-Shinjuku 1-chome, Shinjuku-ku, Tokyo Type of license: Type 1 medical device manufacturer and distributor License...
- Product
- Lot: （1）製品番号 ： CENFT19K ロット番号及び数量（個） H2709212 × 90個 H2856854 × 15個 H2907349 × 40個 H2933863 × 120個 H2937910 × 100個 H2978622 × 50個 H2999167 × 40個 H3019145 × 30個 H3144001 × 84個 H3221338 × 47個 （２）製品番号 ： CENFT23K ロット番号及び個数（個） H2709213 × 180個 H2834187 × 5個 H2834188 × 25個 H2870049 × 225個 H2892155 × 25個 H2898665 × 200個 H2900501 × 45個 H2911451 × 110個 H2934395 × 165個 H2971862 × 115個 H2986161 × 100個 H2986162 × 60個 H2998549 × 40個 H3007025 × 120個 H3019139 × 10個 H3170518 × 60個 H3196713 × 124個 H3201956 × 101個 H3221345 × 90個 （３）製品番号 ： CENFT27K ロット番号及び個数 H2783590 × 10個 H2835374 × 55個 H2884649 × 15個...
- Reason
- We have received a report from an overseas manufacturer that, due to a design defect, the peel-away introducer sheath, which is a component of this product, may not tear correctly from side to side. We have decided to voluntarily recall the subject product because we cannot rule out the possibility of a malfunction or health hazard if the product is used.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Recall date
- 2026-02-27
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/43b454f1-57e8-4050-a121-04a5a8335989