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