Aomori Olympus Co., Ltd. Recall 87074
Description: INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Aomori Olympus Co., Ltd. Recall 87074 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1018-2021 |
| Event ID | 87074 |
| Event Description | INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 7,400,000 (globally); 260,395 (US) |
| Recall Reason | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Device Classification | 20210217 |
| Device Code Info | 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV |
| Center Classification Date | 20210205 |
| Recall Initiation Date | 20210104 |
| Recalling Firm | Aomori Olympus Co., Ltd. |
| Initial Notification | Letter |
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