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Recalled products by Cardinal Health (part 1)
- Starting date:
- October 16, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Labelling and Packaging
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15898
Recalled Products
- Cataract Pack
- Knee Pack
- Hip Pack
- Pacemaker Pack
- Phaco Pack
- Orthopaedic Pack
- Urology Pack
- General Surgery Pack
- Extremity Pack
- Eye Pack
- Cataract Pack
- Plastics Kit
- Knee Pack
- Delivery Pack
- Shoulder Pack
- Prostatectomy Pack
- Craniotomy Pack
- Spinal Pack
- Laparoscopy Packs
- C-Section Pack
- Pack Mammaire
- Lap Pack
- Vascular Pack
- Thoracic Pack
- Aorta/Aneurysm Pack
- Open Heart Bypass Pack
Reason
Some presource packs, kits and modules may not contain the temperature storage statement advising to store product at room temperature (15-30) on the product labelling. The missing temperature and storage information relates to the drugs in the kits and poses no threat or safety issue for the customer. All manufactured product has been stored appropriately during and after manufacture and distribution.
Affected products
A. Cataract Pack
Lot or serial number
116088, 116652, 116996, 117330
Model or catalog number
SEY30CACOE, SEY30CAPGB, SEY30CASBF, SEY30CTPBC
Companies
- Manufacturer
-
Cardinal Health
B. Knee Pack
Lot or serial number
116734, 116736, 116904
Model or catalog number
SOP30ARLAC, SOP30TKTEL, SOP30TKYKH
Companies
- Manufacturer
-
Cardinal Health
C. Hip Pack
Lot or serial number
116738, 117059, 117628, 117754
Model or catalog number
SOP30FHJTF, SOP30HPRGH, SOP30HPSTD, SOP30PHPBC
Companies
- Manufacturer
-
Cardinal Health
D. Pacemaker Pack
Lot or serial number
116963, 116982, 117513
Model or catalog number
SAN30LIKGB, SAN30PAVHE, SCV30PCKGG
Companies
- Manufacturer
-
Cardinal Health
E. Phaco Pack
Lot or serial number
116888
Model or catalog number
MEY30PICEA
Companies
- Manufacturer
-
Cardinal Health
F. Orthopaedic Pack
Lot or serial number
117362
Model or catalog number
SOP30OPMKJ
Companies
- Manufacturer
-
Cardinal Health
G. Urology Pack
Lot or serial number
116086, 117945
Model or catalog number
SBA30URSBD, SOT30MJSM1
Companies
- Manufacturer
-
Cardinal Health
H. General Surgery Pack
Lot or serial number
116533, 117013, 118107, 118339
Model or catalog number
SBA30THGMC, SBA30THHSA, SBA30THSMB, SBA30UPCHB
Companies
- Manufacturer
-
Cardinal Health
I. Extremity Pack
Lot or serial number
SOP30AHCBE, SOP30LCPBC
Model or catalog number
SOP30AHCBE, SOP30LCPBC
Companies
- Manufacturer
-
Cardinal Health
J. Eye Pack
Lot or serial number
118344
Model or catalog number
MEY30BLWGB
Companies
- Manufacturer
-
Cardinal Health
K. Cataract Pack
Lot or serial number
116667
Model or catalog number
SEY30CAVGC
Companies
- Manufacturer
-
Cardinal Health
L. Plastics Kit
Lot or serial number
116012
Model or catalog number
PW30PLPM2
Companies
- Manufacturer
-
Cardinal Health
M. Knee Pack
Lot or serial number
116972, 117892
Model or catalog number
SOP30KNUHS, SOP30TKTTB
Companies
- Manufacturer
-
Cardinal Health
N. Delivery Pack
Lot or serial number
117441
Model or catalog number
SMA30DLCLD
Companies
- Manufacturer
-
Cardinal Health
O. Shoulder Pack
Lot or serial number
116898
Model or catalog number
SOP30SHNLC
Companies
- Manufacturer
-
Cardinal Health
P. Prostatectomy Pack
Lot or serial number
117616, 117766
Model or catalog number
SOT30PRGBA, SOT30PRRRD
Companies
- Manufacturer
-
Cardinal Health
Q. Craniotomy Pack
Lot or serial number
116751
Model or catalog number
SNE30CRVGH
Companies
- Manufacturer
-
Cardinal Health
R. Spinal Pack
Lot or serial number
116910, 117758
Model or catalog number
SBA30SPGHA, SNE30BPQEF
Companies
- Manufacturer
-
Cardinal Health
S. Laparoscopy Packs
Lot or serial number
117608
Model or catalog number
SMA30LPMKH
Companies
- Manufacturer
-
Cardinal Health
T. C-Section Pack
Lot or serial number
116746, 116809, 116864, 116965, 117913, 118266
Model or catalog number
SMA30CCKGI, SMA30CCWRB, SMA30CSBUD, SMA30CSHCA, SMA30CSHMC, SMA30CSOGM
Companies
- Manufacturer
-
Cardinal Health
U. Pack Mammaire
Lot or serial number
116590
Model or catalog number
SBA30MMDLF
Companies
- Manufacturer
-
Cardinal Health
V. Lap Pack
Lot or serial number
116753, 116828, 117050
Model or catalog number
SBA30LPSA1, SLC30LCGHB, SLC30LCSYB
Companies
- Manufacturer
-
Cardinal Health
W. Vascular Pack
Lot or serial number
116790
Model or catalog number
SCV30VARHF
Companies
- Manufacturer
-
Cardinal Health
X. Thoracic Pack
Lot or serial number
116768
Model or catalog number
SCV30THHDD
Companies
- Manufacturer
-
Cardinal Health
Y. Aorta/Aneurysm Pack
Lot or serial number
116817
Model or catalog number
SBA30AAVHF
Companies
- Manufacturer
-
Cardinal Health
Z. Open Heart Bypass Pack
Lot or serial number
116860
Model or catalog number
SCV30OHSMX
Companies
- Manufacturer
-
Cardinal Health