Recalls / —
—#159199
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
- FDA product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Lot no. 6090812
Why it was recalled
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.
Root cause (FDA determination)
Error in labeling
Action the firm took
BD notified their customers on 1/27/2017 via email and/or UPS 2nd Day Mail. Stericycle is handling returns.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Nationwide, Canada
Timeline
- Recall initiated
- 2017-01-27
- Terminated
- 2019-02-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159199. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.