FDAFDA · Food and drugs·Recall number Z-2036-2020
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Published May 27, 2020 · Recall initiated: January 31, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Applied Medical Resources Corp
- Distributor
- 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.
- Lot
- LOT # 1357103, Manufacture Date June 4, 2019; Expiration Date June 2, 2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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