Recall Z-1526-06 ยท KPJ Chamber, Oxygen, Topical, Extremity
Ogenix Corporation
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator,
| Date | Sep 28, 2006 (initiated Mar 24, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 518 |
| Distribution | The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023456 | OXYBOX SYSTEM Oxyfast Corporation, Feb 24, 2003 |