Recall Z-1055-2013— LeMaitre Vascular, Inc.

Name: FDA recall Z-1055-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2013-03-18, terminated 2014-12-03. It names one FDA 510(k) clearance: K932184. Product: Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.. Reason: Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised..

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Terminated: 2014-12-03
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K932184 — STERILE LEMAITRE GLOW 'N TELL TAPEVascutech, Inc.·cleared 1993-07-22

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

Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

Reason for recall

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

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