Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Assembled In Mexico, Bard Access
FDA device recall Z-0862-2010 · posted 2010-02-26 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
- Action taken
- Bard Access Systems, Inc. issued and "Urgent: Huber Plus Non-Coring Needle Safety Infusion Set Recall" notification beginning January 2010. Users were instructed to quarantine all affected product and to notify any of their customers that had received the product. Quarantined product is to be returned to the firm. For further information, contact Bard Access Systems, Inc. at 1-800-290-1689.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 775 units
- Distribution
- Worldwide Distribution -- United States (VA, KY, MA, NJ and TN) and Belgium.
- Date initiated
- 2010-01-14
- Date posted
- 2010-02-26
- Date terminated
- 2010-05-14
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM HUBER PLUS SAFETY INFUSION SET (K993848) | Millennium Medical Distribution, Inc. | 2000-01-27 |