Z-2035-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- January 31, 2020
- Termination Date
- April 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2240 units
Product Description
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Reason for Recall
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
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.
Code Information
LOT # 1360356, Manufacture Date July 5, 2019; Expiration Date July 3, 2024