Device product
SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Z-0985-2021
Product summary
- Event
- Event 87074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,400,000 (global); 260,395 (US)
- Official record key
device-enforcement:Z-0985-2021
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: 05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
inadequate package
-
Sterility assurance
sterile packages with inadequate