Recall Z-0390-2016— LeMaitre Vascular, Inc.

Name: FDA recall Z-0390-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-21

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2015-10-21, terminated 2019-07-12. It names one FDA 510(k) clearance: K992368. Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.. Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Terminated: 2019-07-12
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K992368 — LEMAITRE EMBOLECTOMY CATHETERVascutech, Inc.·cleared 1999-12-09

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

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

Reason for recall

Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

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