Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag
FDA device recall Z-1526-06 · posted 2006-09-28 · Terminated
Recall details
- Recalling firm
- Ogenix Corporation
- Reason for recall
- Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.
- Action taken
- Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPJ
- Quantity affected
- 518
- Distribution
- The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
- Date initiated
- 2006-03-24
- Date posted
- 2006-09-28
- Date terminated
- 2007-12-19
- Location
- Cleveland, 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 |