EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr
FDA device recall Z-1477-2012 · posted 2012-04-30 · Terminated
Recall details
- Recalling firm
- Ogenix Corporation
- Reason for recall
- Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date.
- Action taken
- Ogenix sent a letter dated March 16, 2012 to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to confirm the status of the devices and ship product with the recalled lot back to Ogenix and complete the form provided with the letter.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KPJ
- Quantity affected
- 38 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey.
- Date initiated
- 2012-04-16
- Date posted
- 2012-04-30
- Date terminated
- 2013-02-19
- Location
- Beachwood, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYBOX SYSTEM (K023456) | Oxyfast Corporation | 2003-02-24 |