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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
- STERRAD 50 Cassette
- STERRAD 100 Cassette LIQ 58%
- STERRAD 100NX Cassette
- 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