Device product
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Z-2034-2020
Product summary
- Event
- Event 85421
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2240 units
- Official record key
device-enforcement:Z-2034-2020
Official wording
Reason: Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Code information: LOT # 1359929, Manufacture Date June 28, 2019; Expiration Date June 26, 2024
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KY, MA, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA. WA and WI. The countries of Austria, Australia, Canada, Switzerland, Germany, Spain, Finland, France, Italy, Japan, Mexico, and Netherlands.
Derived failure modes
-
Unknown
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.