Health product recall

Centeze Centesis Catheter (2018-05-01)

Starting date:
May 1, 2018
Posting date:
May 11, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66744

Affected products

Centeze Centesis Catheter

Reason

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Affected products

Centeze Centesis Catheter

Lot or serial number
  • 17311642
  • 17311643
  • 17314337
  • 17349257
  • 17352567
Model or catalog number
  • DRC-002-05
  • DRC-002-06
  • DRC-002-08
Companies
Manufacturer
Galt Medical Corporation
2220 Merritt drive
Garland
75041
Texas
UNITED STATES