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MED-RX ANESTHESIA KIT (2016-05-19)
- Starting date:
- May 19, 2016
- Posting date:
- June 13, 2016
- 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-58832
Affected products
A. MED-RX ANESTHESIA KIT
Reason
Omega Laboratories, the supplier of sodium chloride, identified an out-of-specification (OOS) stability result for the pH value at the 12 month testing interval at 25 degrees celsius. Found result is 7.6 (limit is 7.0). The product shelf life is 48 months and the lot is out-of-specification before expiry. MED-RX anesthesia kits contain this component.
Affected products
A. MED-RX ANESTHESIA KIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 80-8004
- 80-8005
- 80-8006
- 80-8018
- 80-8022
- 80-8023
- 80-8025
- 80-8026
- 80-8033
- 80-8034
- 80-8040
- 80-8042
- 80-8060N
- 80-8066
- 80-8074
- 80-8082
- 80-8083
- 80-8090
- 80-8091
- 80-8108
- 80-8131
- 80-8135
- 80-8138
- 80-8139
Companies
- Manufacturer
-
CANADIAN HOSPITAL SPECIALTIES LTD. DOING BUSINESS AS CHS
2760 BRIGHTON ROAD
OAKVILLE
L6H 5T4
Ontario
CANADA