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Health product recall

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