BD Vacutainer Luer Adapter; Catalog #367290 and #367300.
FDA device recall Z-1462-06 · posted 2006-09-09 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
- Action taken
- BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 3,324,000 units
- Distribution
- World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, N
- Date initiated
- 2006-06-21
- Date posted
- 2006-09-09
- Date terminated
- 2007-06-07
- 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 BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE (K991088) | Becton Dickinson Vacutainer Systems | 1999-05-28 |