Z-2037-2020 Class II Terminated
FDA device recall Z-2037-2020 was initiated by Applied Medical Resources Corp on January 31, 2020 and is designated Class II. Reason for recall: Failure of cardiovascular clips to provide sufficient occlusion of the vessel. The recall status is terminated (terminated April 20, 2022). Affected quantity: 750 units.
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
- 750 units
Product Description
STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - 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 # 1360163, Manufacture Date July 3, 2019; Expiration Date July 3, 2024