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1.8mm Expandable LeMaitre Valvulotome (2014-07-28)
- Starting date:
- July 28, 2014
- Posting date:
- August 15, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41063
Recalled products
- 1.8mm Expandable LeMaitre Valvulotome
Reason
Lemaitre accidentally shipped an unlicensed version of the expandable LeMaitre Valvulotome to Canada. The unlicensed version is identical to the licenced version except that the IFU’s are provided in electronic format only. The medical devices regulations does not allow for the provision of IFU’s in electronic format only.
Affected products
A. 1.8mm Expandable LeMaitre Valvulotome
Lot or serial number
- Lot# ELV32268V, Exp: 2018-10
Model or catalog number
- E1000-90
- E1000-95
Companies
- Manufacturer
-
Lemaitre Vascular
63 Second Avenue
Burlington
01803
Massachusetts
UNITED STATES