Product Wiki · Recalls · Health Canada — Medical Devices

Various Medlines' Custom Procedure Packs (2018-04-06) — recall 60901

Health Canada — Medical Devices · Canada · 2018-05-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
60901
Date of alert
2018-05-04
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/various-medlines-custom-proced

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