ClearanceBrief
Recall Z-0084-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Becton Dickinson & Company

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

DateJan 27, 2017
StatusTerminated
ReasonAfter 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.
Root causeError in labeling
ActionBD notified their customers on 1/27/2017 via email and/or UPS 2nd Day Mail. Stericycle is handling returns.
Quantity90,000 tubes
DistributionNationwide, Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.