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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