Medical device recalls Moderate risk

BD Vacutainer Sodium Polyanetholesulfonate 5 recalled over labeling errors

Recall date
January 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Becton Dickinson & Company recalls BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological S…
Recall number
Z-0084-2018
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Nationwide, Canada

Why it was recalled

After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level.

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 Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960

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