Device product
NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
Z-1069-2021
Product summary
- Event
- Event 87074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Official record key
device-enforcement:Z-1069-2021
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, 02K, 03K, 04K, 05K, 06K, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
inadequate package
-
Sterility assurance
sterile packages with inadequate