R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Pro
FDA device recall Z-1850-2020 · posted 2020-04-16 · Terminated
Recall details
- Recalling firm
- Epimed International
- Reason for recall
- Incorrect expiration date on introduction cannula packaging.
- Action taken
- On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 701
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AL, CA, FL, GA, IL, MD,MI, MS, NJ, NY, OK, TN, TX, WA and WY and the countries of Australia, Chile, United Kingdom.
- Date initiated
- 2020-02-21
- Date posted
- 2020-04-16
- Date terminated
- 2021-01-28
- Location
- Farmers Branch, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RF INTRODUCTION CANNULA (K041021) | Epimed International, Inc. | 2004-09-16 |