Recall Z-2034-2020 ยท DSS Clip, Vascular
Applied Medical Resources Corp
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.
| Date | Jan 31, 2020 |
| Status | Terminated |
| Reason | Failure of cardiovascular clips to provide sufficient occlusion of the vessel. |
| Root cause | Nonconforming Material/Component |
| Action | On 01/31/2020, Customer Notification Letter was sent to all consignees/ distributors requesting them to return the affected devices to the recalling firm. |
| Quantity | 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, Mexic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883909 | SURGICAL SPRING CLIPS Applied Vascular Devices, Inc., Dec 27, 1988 |