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

• 
  Reason
• 
  Affected products

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