Sterile C Section Pack, Bone Marrow Tray, Sterile Labour and Delivery Pack, Sterile Obstetrical Pack, Sterile Delivery Pack, and Bone Marrow Biopsy Pack from Cardinal Health (2018-04-17)
- Starting date:
- April 17, 2018
- Posting date:
- May 1, 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-66642
Affected products
A. STERILE C SECTION PACK
B. BONE MARROW TRAY
C. STERILE LABOUR AND DELIVERY PACK
D. STERILE OBSTETRICAL PACK
E. STERILE DELIVERY PACK
F. BONE MARROW BIOPSY PACK
Reason
Cardinal Health has been advised of an advisory notice on BD Vacutainer Top Tubes contained in these kits. BD has recently determined that the curing agent thiuram, used in the processing of rubber stoppers since 1996, can lead to release of Carbon Disulfide (CS2) and Carbonyl Sulfide (COS) gases into the headspace of the tubes. These gases can dissolve into the blood sample to chelate lead, and therefore interfere with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. Although the thiuram has been used since at least 1996, the release of CS2 and COS gases into the headspace and their effect on ASV methodology was only recently observed. ASV is the methodology used in magellan diagnostics' leadcare testing systems.
Affected products
A. STERILE C SECTION PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SMA30CSCLG
SMA30CEMHD
SMA30CSQUL
SMA30CSWEF
SMA30CTCHG
SMA30CSQUJ
SMA30CTCHF
SMA30CSQUK
SOP30BMWPA
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES
B. BONE MARROW TRAY
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SOP30BM00C
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES
C. STERILE LABOUR AND DELIVERY PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SMA30BILBJ
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES
D. STERILE OBSTETRICAL PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SMA30OBPNG
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES
E. STERILE DELIVERY PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SMA30DLCLG
SMA30LDRHF
SMA30DECUA
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES
F. BONE MARROW BIOPSY PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SBA30BMHMA
Companies
- Manufacturer
-
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES