Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344

Recall date
March 20, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1532-2018
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania

Why it was recalled

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344

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