Health product recall

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