FDA recall Z-2035-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2020-01-31

Report date

2020-05-27

Termination date

2022-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rancho Santa Margarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2020