Olympus Corporation of the Americas Recall 92325
Description: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Olympus Corporation of the Americas Recall 92325 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1987-2023 |
| Event ID | 92325 |
| Event Description | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 340 pieces |
| Recall Reason | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure. |
| Device Classification | 20230628 |
| Device Code Info | UDI-DI: 04953170385919 Lot Numbers: 24K, 27K, 29K, 2XK, 2YK |
| Center Classification Date | 20230621 |
| Recall Initiation Date | 20230504 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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