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Health product recall

LeMaitre Over-The-Wire Catheter (2015-10-27)

Starting date:
October 27, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-55870

Affected Products

LeMaitre Over-The-Wire Catheter

Reason

A manufacturing issue could cause a pinhole in the formed end of the packaging tubes for this device, and the sterility of these products could be compromised.

Affected products

LeMaitre Over-The-Wire Catheter

Lot or serial number

L/N OTW3046 EXP: 2021-02
L/N OTW3113 EXP: 2021-06

Model or catalog number

1651-88
E1651-78

Companies
Manufacturer
Lemaitre Vascular
63 Second Avenue
Burlington
01803
Massachusetts
UNITED STATES