Z-0084-2018 Class II Terminated
FDA device recall Z-0084-2018 was initiated by Becton Dickinson & Company on January 27, 2017 and is designated Class II. 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 p… The recall status is terminated (terminated February 6, 2019). Affected quantity: 90,000 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- January 27, 2017
- Termination Date
- February 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90,000 tubes
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.
Distribution Pattern
Nationwide, Canada
Code Information
Lot no. 6090812