FDA recall Z-0084-2018

Product

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

Reason for recall

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.

Distribution

Nationwide, Canada

Key facts

Status

Terminated

Initiation date

2017-01-27

Report date

2017-11-15

Termination date

2019-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0084-2018