Cardinal Healths' Presource Kits (2018-03-06)
- Starting date:
- March 6, 2018
- Posting date:
- March 21, 2018
- 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-66198
Affected products
A. CATHETERIZATION PACK
B. LAP CHOLE PACKS
C. KNEE PACKS
D. CARDIAC CATHETERIZATION PACKS
E. MINOR LAPAROTOMY PACKS
F. ENSEMBLE CORONARY
G. MAXIMAL BARRIER
H. EP PACK
I. C SECTION PACK
J. ENSEMBLE PACEMAKER
K. MINOR LITHOTONY PACKS
L. MAJOR LAPAROTOMY PACKS
M. TRANSVERSE LAPAROTOMY PACKS
Reason
Cardinal health presource kits were exposed to temperature variations during transportation which are outside the range of the supplier's approved labelling. As such, these temperature excursions may have impacted the effectiveness of certain components within the kits.
Affected products
A. CATHETERIZATION PACK
Lot or serial number
468183
Model or catalog number
SAN30CLJGG
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
B. LAP CHOLE PACKS
Lot or serial number
468653
Model or catalog number
SLC30LCNLF
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
C. KNEE PACKS
Lot or serial number
468249
Model or catalog number
SOP30TKRMC
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
D. CARDIAC CATHETERIZATION PACKS
Lot or serial number
468238
468563
468870
469135
Model or catalog number
SAN30CCSLH
SAN30CCUA1
SAN30CLCRE
SAN30CLSLR
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
E. MINOR LAPAROTOMY PACKS
Lot or serial number
469042
Model or catalog number
SBA30MNNLE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
F. ENSEMBLE CORONARY
Lot or serial number
469013
Model or catalog number
SAN30ECVOD
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
G. MAXIMAL BARRIER
Lot or serial number
468720
Model or catalog number
SBA30MBKGA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
H. EP PACK
Lot or serial number
467711
Model or catalog number
SCV30EPUA1
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
I. C SECTION PACK
Lot or serial number
467754
468174
469012
Model or catalog number
SMA30CSLBM
SMA30CSPLF
SMA30CSSDC
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
J. ENSEMBLE PACEMAKER
Lot or serial number
468173
Model or catalog number
SCV30PCUAE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
K. MINOR LITHOTONY PACKS
Lot or serial number
468401
Model or catalog number
SBA30LTNLE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
L. MAJOR LAPAROTOMY PACKS
Lot or serial number
468337
Model or catalog number
SBA30MLNLE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
M. TRANSVERSE LAPAROTOMY PACKS
Lot or serial number
467489
Model or catalog number
SBA30TRNHJ
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES