Recall Z-2034-2020— Applied Medical Resources Corp

Name: FDA recall Z-2034-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-31

Class II · Terminated

Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2020-01-31, terminated 2022-04-20. It names one FDA 510(k) clearance: K883909. 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.. Reason: Failure of cardiovascular clips to provide sufficient occlusion of the vessel..

Recalling firm: Applied Medical Resources Corp
Classification: Class II
Status: Terminated
Initiated: 2020-01-31
Terminated: 2022-04-20
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K883909 — SURGICAL SPRING CLIPSApplied Vascular Devices, Inc.·cleared 1988-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.