Device product
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - 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.
Z-0997-2021
Product summary
- Event
- Event 87074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Official record key
device-enforcement:Z-0997-2021
Official wording
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.
Code information: 01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
inadequate package
-
Sterility assurance
sterile packages with inadequate