AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for E
FDA device recall Z-0215-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Soma Access Systems LLC
- Reason for recall
- There is a possibility the sterile packaging may fail before the expiration date specified on the package.
- Action taken
- Consignees were notified via USPS Certified Letter, email and FedEx on 3/24/2014.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 3530 units
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, In
- Date initiated
- 2014-03-24
- Date posted
- 2014-12-16
- Date terminated
- 2015-08-06
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT (K113680) | Soma Access Systems, LLC | 2011-12-29 |