Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usag
FDA device recall Z-0899-2015 · posted 2014-12-30 · Completed
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Needle is not captured in the needle safety sheath in specific lots.
- Action taken
- Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.
- Root cause
- Process control
- Status
- Completed
- Product code
- FMI
- Quantity affected
- 10,000
- Distribution
- US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
- Date initiated
- 2014-11-21
- Date posted
- 2014-12-30
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE (K041399) | Smiths Medical Asd, Inc. | 2004-07-28 |