BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton Dickinson and Company, Frankl
FDA device recall Z-1023-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
- Action taken
- Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
- Root cause
- Other
- Status
- Terminated
- Product code
- JSM
- Quantity affected
- 344950
- Distribution
- Nationwide distribution to hospitals and medical device distributors.
- Date initiated
- 2009-10-12
- Date posted
- 2010-03-08
- Date terminated
- 2010-03-10
- 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 VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (K024240) | Bd | 2003-03-26 |