Recall Z-0084-2018— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2017-01-27, terminated 2019-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-27
- Terminated
- 2019-02-06
- Firm location
- Franklin Lakes, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.