BACTISEAL EVD Catheter Set, CODMAN Peritoneal Catheter, Ventricular and Peritoneal Catheter Set, CODMAN Ventricular Catheter with BACTISEAL (2019-03-14)
- Starting date:
- March 14, 2019
- Posting date:
- April 29, 2019
- 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-69710
Last updated: 2019-04-30
Affected Products
A. BACTISEAL EVD Catheter Set
B. CODMAN Peritoneal Catheter with BACTISEAL
C. CODMAN Ventricular and Peritoneal Catheter Set with BACTISEAL
D. CODMAN Ventricular Catheter with BACTISEAL
Reason
Precaution was added to the instructions to inform customers to only use sterile water or normal saline to immerse the bactiseal catheter as other solutions are not recommended and may cause precipitation and consequent adverse effects (e.g., catheter occlusion, hydrocephalus). The precaution also advised customers to keep the time the bactiseal catheter immersed in sterile water or normal saline to a minimum (i.e., seconds) to reduce the risk of introducing infectious agents.
Affected products
A. BACTISEAL EVD Catheter Set
Lot or serial number
Sold from Jan 2018 to Mar 2019.
Model or catalog number
- 82-1745
- 82-1750
Companies
- Manufacturer
-
Codman & Shurtleff Inc.
325 Paramount Drive
Raynham
02767-0350
Massachusetts
UNITED STATES
B. CODMAN Peritoneal Catheter with BACTISEAL
Lot or serial number
Sold from Jan 2018 to Mar 2019.
Model or catalog number
82-3074
NS0339
Companies
- Manufacturer
-
Codman & Shurtleff Inc.
325 Paramount Drive
Raynham
02767-0350
Massachusetts
UNITED STATES
C. CODMAN Ventricular and Peritoneal Catheter Set with BACTISEAL
Lot or serial number
Sold from Jan 2018 to Mar 2019.
Model or catalog number
82-3072
Companies
- Manufacturer
-
Codman & Shurtleff Inc.
325 Paramount Drive
Raynham
02767-0350
Massachusetts
UNITED STATES
D. CODMAN Ventricular Catheter with BACTISEAL
Lot or serial number
Sold from Jan 2018 to Mar 2019.
Model or catalog number
82-3073
Companies
- Manufacturer
-
Codman & Shurtleff Inc.
325 Paramount Drive
Raynham
02767-0350
Massachusetts
UNITED STATES