BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL,
FDA device recall Z-0911-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.
- Action taken
- BD sent advisory letters via UPS dated 3/5/2012 to customers. The letter identified the affected product and the reason for recall. BD has taken steps to modify the existing manufacturing and assembly processes to help reduce the potential for this condition. Questions regarding this issue should be directed to BD Global Technical Services at 1-800-631-0174 or email at www.bd.com/Vascutainer/contact.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 225 million units
- Distribution
- Nationwide Distribution
- Date initiated
- 2012-03-05
- Date posted
- 2013-03-06
- Date terminated
- 2015-07-20
- 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 |
|---|---|---|
| VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE (K945952) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-01-18 |