Class 2 Device Recall EpiFLO SD

• Date Initiated by Firm: March 24, 2006
• Date Posted: September 28, 2006
• Recall Status: Terminated on December 19, 2007
• Recall Number: Z-1526-06
• Recall Event ID: 36130
• 510(K)Number: K023456
• Product Classification: transdermal oxygen therapy device - Product Code KPJ
• Product: 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, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
• Code Information: A total of 18 lot codes were distributed. They are as follows: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
• Recalling Firm/ Manufacturer: Ogenix Corporation; 23230 Chagrin Blvd; Suite 950; Cleveland OH 44122-5461
• For Additional Information Contact: 216-658-3969
• Manufacturer 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.
• FDA Determined 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 in Commerce: 518
• Distribution: The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPJ