BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Compa
FDA device recall Z-1746-2017 · posted 2017-04-06 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.
- Action taken
- BD sent an "Urgent Product Correction Letters and Customer Product Correction Response Forms" dated March 16, 2017 via email or UPS to their customers and distributors.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 13,064,500 tubes (non-expired)
- Distribution
- Worldwide - US Nationwide Distribution
- Date initiated
- 2017-03-16
- Date posted
- 2017-04-06
- Date terminated
- 2018-05-01
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE (K945952) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-01-18 |