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.
- Recall Initiated
- January 31, 2020
- Terminated
- April 20, 2022
- Recall Number
- Z-2034-2020
- Quantity
- 2240 units
- Firm Location
- Margarita, CA
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.
Lot / Code Info
LOT # 1359929, Manufacture Date June 28, 2019; Expiration Date June 26, 2024
Root Cause
Nonconforming Material/Component
Action Taken
On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm.
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