Health product recall

Vista 3mL 3% & 6% Sodium Hypo Kit (2019-07-30)

Starting date:
July 30, 2019
Posting date:
May 29, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73191

Last updated: 2020-05-29

Affected Products

  1. Vista 3mL 3% Sodium Hypo Kit
  2. Vista 3mL 6% Sodium Hypo Kit

Reason

The affected lots may be packaged in syringes which include an incorrect bung attached to the plunger. The specified bung is made of a silicone-based material, whereas the incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution. When extruded, affected solutions may appear discolored (yellow/gray/black), or may contain small particulate matter. Affected material may contain percentages of sodium hypochlorite lower than those communicated on the labeling.

Affected products

A. Vista 3mL 3% Sodium Hypo Kit

Lot or serial number
  • 20182545
  • 20182665
  • 20190198
  • 20190432
  • 20190724
  • 20190953
  • 20191314
Model or catalog number

502355

Companies
Manufacturer
INTER-MED, INC.
2200 South Street
Racine
53404
Wisconsin
UNITED STATES

B. Vista 3mL 6% Sodium Hypo Kit

Lot or serial number
  • 20190197
  • 20190723
  • 20190834
  • 20190862
  • 20190952
Model or catalog number

502350

Companies
Manufacturer
INTER-MED, INC.
2200 South Street
Racine
53404
Wisconsin
UNITED STATES