Device 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
Z-0084-2018
Product summary
- Event
- Event 78329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90,000 tubes
- Official record key
device-enforcement:Z-0084-2018
Official wording
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.
Code information: Lot no. 6090812
Distribution pattern: Nationwide, Canada
Derived failure modes
-
Labeling or packaging
incorrect labeling