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Health product recall

I-CEL (2% HPMC) (2015-10-19)

Starting date:
October 19, 2015
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-56186

Affected Products

  1. I-CEL (2% HPMC)
  2. I-CEL (2% HPMC)

Reason

Product does not conform to product specification requirements for a pH value of 6.8 to 7.6 as per ISO 15798 ophtalmic implants.

Affected products

A. I-CEL (2% HPMC)

Lot or serial number
  • V0115F
  • V0115F
  • V0315M
  • V0315M
  • V0914A
  • V0914A
    Model or catalog number
    • 515
    • 515
    Companies
    Manufacturer
    I-Med Pharma Inc.
    1601 St-Regis
    Montreal Québec
    H9B 3H7
    Quebec
    CANADA

    B. I-CEL (2% HPMC)

    Lot or serial number

    V0115F
    V0115F
    V0315M
    V0315M
    V0914A
    V0914A

    Model or catalog number

    515
    515

    Companies
    Manufacturer
    I-Med Pharma Inc.
    1601 St-Regis
    Montreal Québec
    H9B 3H7
    Quebec
    CANADA

    Date modified: