Recall Z-1029-2021 ยท FGX Snare, Non-Electrical
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - 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.
| Date | Jan 4, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On January 4, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the identified list of Endo-therapy devices may have a defective seal which may compromise the sterility of the product. Customers were asked to take the following actions: 1. Immediately assess any product you have in stock to identify endotherapy products with affected lot numbers listed in the recall letter. Cease use of product and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Good |
| Quantity | 7,400,000 (globally); 260,395 (US) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172734 | Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp., Dec 7, 2017 |