BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298
FDA device recall Z-0619-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.
- Action taken
- Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MEG
- Quantity affected
- 334,400 units
- Distribution
- GA, KS, OH, MO, FL, PA, KY and NY.
- Date initiated
- 2008-11-24
- Date posted
- 2009-01-13
- Date terminated
- 2009-03-27
- 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 |
|---|---|---|
| BD INTEGRA SYRINGE (K023752) | Bd | 2003-02-07 |