Various Medlines' Custom Procedure Packs (2018-04-06)
- Starting date:
- April 6, 2018
- Posting date:
- May 4, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66688
Affected products
A. Cesarienne-LF / C Section BJC-LF
B. Vaginal Delivery Pack
C. C-Section Pack-LF / C-Section-LF
D. New Tissue Retrieval MH
E. Ensemble A Cesarienne-LF
F. Vaginal Delivery Pack - LF
Reason
Medline Industries received a Medical Device Correction Notice from BD concerning their BD Vacutainer EDTA Lavender, Tan & Pink Top Tubes & BD Vacutainer Lithium Heparin Green Top Tubes. 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.
The BD Vacutainer EDTA Lavender, Tan and Pink Top Tubes & BD Vacutainer Lithium Heparin Green Top Tubes are a component in several Medline Custom Procedure Packs.
Affected products
A. Cesarienne-LF / C Section BJC-LF
Lot or serial number
17WB9664
18MB3317
18NB1557
Model or catalog number
DYNJ41672X
DYNJ42677X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
B. Vaginal Delivery Pack
Lot or serial number
17KB1919
18CB1558
Model or catalog number
DYNJ47920X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
C. C-Section Pack-LF / C-Section-LF
Lot or serial number
18MB5551
18MB9683
Model or catalog number
DYNJ45915X
DYNJ47509X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
D. New Tissue Retrieval MH
Lot or serial number
17XB2402
18BB7218
18NB1353
Model or catalog number
DYNJ903849X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
E. Ensemble A Cesarienne-LF
Lot or serial number
18BB9026
Model or catalog number
DYNJ57105X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
F. Vaginal Delivery Pack - LF
Lot or serial number
17YB1732
181B4881
18OB3146
Model or catalog number
DYNJ45914X
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES