Generic Name: (1), (2) Washer-disinfector For Decontaminating Medical Devices — Trade Name: (1) Washer-disinfector Mat Ld500 — (2) Washer-disinfector Mat Ld1000
Recall Summary Two models of washer-disinfectors used in hospitals to clean and disinfect reusable surgical instruments are being recalled due to errors on their statutory labeling. A total of 94 units of the MAT LD500 and MAT LD1000 models were distributed, and the manufacturer will apply corrected labels to affected devices. The manufacturer states there are no quality, safety, or effectiveness issues with the devices themselves and no health incidents have been reported.
- Recalling firm
- Name of Manufacturer and Distributor: Udon Medical Equipment Co., Ltd., Narahara Plant — Address of Manufacturer and Distributor: 1453-2 Narahara-cho, Hachioji City, Tokyo — Type of License: Type...
- Product
- Lot: （1）ウォッシャーディスインフェクター MAT LD500 製造番号: 074555, 074567, 074616, 074617, 074580, 074603, 074662, 074632, 074633, 074634, 074761, 074811, 0748 12, 074841, 074842, 074855, 074856, 074925, 075076, 075045, 074996, 075086, 075009, 075010, 075011, 075012, 075082, 075083, 075113, 075118, 075119, 075112, 075144, 075145, 075171, 075157, 075158, 0751 77, 075267, 075286, 075238, 075239, 075227, 075311, 075422, 075423, 075443, 075434, 075401, 075538, 075535, 075591, 075626, 075581, 075571, 075572, 075549, 075596, 075675, 075704, 075705, 075721, 0757 58, 075759, 075821, 075725, 075726, 075820, 075878...
- Reason
- It has been determined that the statutory label affixed to the product in question contains errors regarding the mandatory labeling requirements for medical devices. Therefore, we will conduct a voluntary recall for products delivered within the specified period by applying a new statutory label with the correct information.
- Classification
- Class III
- 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/3abd71a1-10e5-4493-a597-c3251dd67542