International safety notice
(a) During the sterilization process of the product, it was confirmed that there was a record defect in the sterilization process for a specific product lot, and the product was classified as a medical device. It has become clear that the required sterility assurance level cannot be guaranteed. However, as the validity of the manufacturing process for this product cannot be confirmed, we are implementing a voluntary recall of the relevant lot of this product. I said. (b) As a result of an additional internal investigation and QMS review, we determined that the records for the sterilization process were non-conforming. We have decided to carry out additional voluntary recalls for other product lots.
Japan / PMDA Recalls · JPN · Feb 3, 2023
Key facts
| Title | (a) During the sterilization process of the product, it was confirmed that there was a record defect in the sterilization process for a specific product lot, and the product was classified as a medical device. It has become clear that the required sterility assurance level cannot be guaranteed. However, as the validity of the manufacturing process for this product cannot be confirmed, we are implementing a voluntary recall of the relevant lot of this product. I said. (b) As a result of an additional internal investigation and QMS review, we determined that the records for the sterilization process were non-conforming. We have decided to carry out additional voluntary recalls for other product lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Embryo transfer catheter (2) Soft tissue biopsy kit (3) Artificial insemination catheter (4) Embryo transfer catheter (5) Catheter for tubal canalization testing (*) (6) Single-use endoscopic non-active treatment device for natural orifice (7) Single-use endoscopic treatment device for natural orifice Endoscopy Cannula (8)Reusable Aspiration Needle (9)Reusable Biopsy Needle (10)Aspiration Tube (11)Reusable Injection Injection needle (12) Single-use non-active endoscopic treatment device for natural orifice (13) Reusable non-active treatment device for endoscope (14) Gynecological use Stripper (15) Uterine catheter for semen injection (16) Uterine catheter for semen injection (17) Uterine catheter for semen injection (*) Brand name: (1) Kitazato ET catheter (2) Kitazato OPU needle (3) Kitazato IUI catheter (4) Towako method (5) Kitazato salpingography balloon catheter (*) (6) Kitazato EDS catheter (7) Kitazato SHG cannula (8) Kitazato suction needle (9) Kitazato biopsy needle (10) Aspiration line (11) Kitazatkatelan needle (12) Sugiyama catheter (13) IVA cannula (14) Kirby Cannula (15) Blue eye (16) Pink eye (17) White Eye (*) |
| Manufacturer | Kitasato Corporation Co., Ltd. |
| Models | S21129, S01224, C01218, S10325, S10604, C00714, S21101, C00710, S20823, F21124, S10729, C00719 and 97 more |
| Date | Feb 3, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1