Z-1002-2021 Class II Terminated
FDA device recall Z-1002-2021 was initiated by Aomori Olympus Co., Ltd. on January 4, 2021 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated March 11, 2024). Affected quantity: 7,400,000 (globally); 260,395 (US).
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 4, 2021
- Termination Date
- March 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,400,000 (globally); 260,395 (US)
Product Description
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV