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Health product recall

STERRAD Product Recall (2014-12-08)

Starting date:
December 8, 2014
Posting date:
December 12, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42919

Recalled Products

  1. STERRAD 50 Cassette
  2. STERRAD 100 Cassette LIQ 58%
  3. STERRAD 100NX Cassette
  4. STERRAD NX Cassette

Reason

The leak indicator on the STERRAD System cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. The leak indicator is designed to provide a visual color indication (it turns from yellow to red) in the event hydrogen peroxide has leaked form the cassettes, however, it may be unstable and may not remain red for the duration of the products' shelf-life.

Depth of distribution

Hospitals

Affected products

A. STERRAD 50 Cassette

DIN, NPN, DIN-HIM
DIN 02250365
Dosage form

Liquid

Strength

Hydrogen Peroxide 58%

Lot or serial number

All Lots

Companies
Recalling Firm
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA
Marketing Authorization Holder
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA

B. STERRAD 100 Cassette LIQ 58%

DIN, NPN, DIN-HIM
DIN 01980475
Dosage form

Liquid

Strength

Hydrogen Peroxide 58%

Lot or serial number

All Lots

Companies
Recalling Firm
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA
Marketing Authorization Holder
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA

C. STERRAD 100NX Cassette

DIN, NPN, DIN-HIM
DIN 02296667
Dosage form

Liquid

Strength

Hydrogen Peroxide 58%

Lot or serial number

All Lots

Companies
Recalling Firm
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA
Marketing Authorization Holder
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA

D. STERRAD NX Cassette

DIN, NPN, DIN-HIM
DIN 02253194
Dosage form

Liquid

Strength

Hydrogen Peroxide 58%

Lot or serial number

All Lots

Companies
Recalling Firm
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA
Marketing Authorization Holder
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham
L3R 0T5
Ontario
CANADA

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