Device product
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Z-1070-2021
Product summary
- Event
- Event 87074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,400,000 (globally); 260,395 (US)
- Official record key
device-enforcement:Z-1070-2021
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, 07K, 08K, 09K, 0XK, 93K, 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