Health product recall

0.9% Saline Wound Irrigation (2019-09-06)

Starting date:
September 6, 2019
Posting date:
September 20, 2019
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-71023



Last updated: 2019-09-20

Affected Products

0.9% Saline Wound Irrigation

Reason

Integra LifeSciences identified through complaints that batches of sterile saline 0.9% (SKU 48501) were mislabeled as sterile water (SKU 48801). The affected lots of sterile saline SKU#  48501 are as follows: e19353, e19366, e19391, e19395.

Affected products

0.9% Saline Wound Irrigation

Lot or serial number
  • E19353
  • E19366
  • E19391
  • E19395
Model or catalog number

48501

Companies
Manufacturer

Derma Sciences, Inc.

104 Shorting road

Toronto

M1S 3S4

Ontario

CANADA