BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with e
FDA device recall Z-2542-2014 · posted 2014-08-22 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
- Action taken
- BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JCF
- Quantity affected
- 296,160 tubes
- Distribution
- US and Foreign
- Date initiated
- 2014-07-03
- Date posted
- 2014-08-22
- Date terminated
- 2016-05-03
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (K911731) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-12-15 |
| LEUCOPREP CELL SEPARATION TUBE (K891407) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-05-26 |