Recall Z-1847-2020— Applied Medical Resources Corp

Name: FDA recall Z-1847-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Class I · Terminated

Class I FDA medical device recall by Applied Medical Resources Corp, initiated 2019-10-24, terminated 2023-06-01. It names one FDA 510(k) clearance: K970762. Product: Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y. Reason: The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter..

Recalling firm: Applied Medical Resources Corp
Classification: Class I
Status: Terminated
Initiated: 2019-10-24
Terminated: 2023-06-01
Firm location: Rancho Santa Margarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K970762 — DUAL LUMEN EMBOLECTOMY CATHETERApplied Medical Resources·cleared 1997-03-28

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

Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y

Reason for recall

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

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