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.
Reported: May 27, 2020 Initiated: January 31, 2020 #Z-2034-2020
Product Description
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.
Reason for Recall
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Details
- Recalling Firm
- Applied Medical Resources Corp
- Units Affected
- 2240 units
- 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.
- Location
- Rancho Santa Margarita, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Applied Medical Resources Corp. Units affected: 2240 units.
Why was this product recalled? ▼
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2034-2020.
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