Health product recall

GORE PROPATEN VASCULAR GRAFT (2021-05-13)

Starting date:
May 13, 2021
Posting date:
May 20, 2021
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-75645



Last updated:
2021-05-20

Affected Products 

GORE PROPATEN VASCULAR GRAFT

Reason

Potential for mislabeled devices.

HPT050010A devices labeled as having a 5mm Inner Diameter (ID) may contain a 6mm ID device.

HPT060015A  devices labeled as having a 6mm Inner Diameter (ID) may contain a 5mm ID device.

Affected products

GORE PROPATEN VASCULAR GRAFT

Lot or serial number

6185495PP011

6185495PP014

6185495PP015

Model or catalog number

HPT050010A

Companies
Manufacturer

W.L. GORE & ASSOCIATES INC

1505 NORTH 4TH STREET

FLAGSTAFF

86004

Arizona

UNITED STATES