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Recall Observatory FDA recall evidence

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

January 31, 2020

Class II

Product summary

Firm
Applied Medical Resources Corp
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

    reason.no_named_rule · v1.0.0

    Failure of cardiovascular clips to provide sufficient occlusion of the vessel.