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IRMA TRUpoint Cartridges (2015-09-16)
- Starting date:
- September 16, 2015
- Posting date:
- October 22, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55522
Affected Products
- A. IRMA TRUpoint CC Cartridges
- B. IRMA TRU point BG (Blood Gas) Cartridges
Reason
The affected lots may report values outside the performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated.
Affected products
A. IRMA TRUpoint CC Cartridges
Lot or serial number
ASBEZ
ASCXE
ASEMB
ASHWQ
ASJMY
ASLGI
ASMXR
ASOQO
ASRXC
ASTQR
ASWZI
Model or catalog number
39903
Companies
- Manufacturer
-
LifeHealth, LLC
2656 PATTON ROAD
Roseville
55113
Minnesota
UNITED STATES
B. IRMA TRU point BG (Blood Gas) Cartridges
Lot or serial number
EOSCU
EOTUZ
EOVMW
EOYUL
EPANW
EPCED
EPDVM
EPFOJ
EPIXX
EPKOJ
EPNXA
Model or catalog number
048103
Companies
- Manufacturer
-
LifeHealth, LLC
2656 PATTON ROAD
Roseville
55113
Minnesota
UNITED STATES