Class 2 Device Recall Catheter Insertion Kit

• Date Initiated by Firm: March 24, 2011
• Date Posted: May 03, 2011
• Recall Status: Terminated on February 28, 2012
• Recall Number: Z-2133-2011
• Recall Event ID: 58278
• Product Classification: Catheter care tray - Product Code OHR
• Product: Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations
• Code Information: Catalog Reference number: 6100A, Lot numbers: 8315, 9317, 0317, 9G176, 0C046, 0G226, 0K186, 1A316, 8316, 9318, 0318, 9G206, 0C086, 0G236, 0K196, 1B016, 8317, 9320, 0319, 9G236, 0C096, 0G246, 0K206, 1B026, 8319, 9321, 0320, 9G286, 0C106, 0G296, 0K226, 1B036, 8320, 9324, 0321, 9G296, 0C186, 0G306, 0K236, 1B046, 8321, 9325, 0322, 9H066, 0C196, 0H216, 0K246, 1B056, 8324, 9326, 0323, 9H076, 0C206, 0H226, 0K256, 1B076, 8325, 9327, 0324, 9H086, 0C226, 0H266, 0K286, 1B186, 8326, 9328, 0325, 9H126, 0C236, 0H276, 0K296, 1B196, 8327, 9329, 0326, 9H176, 0C256, 0H286, 0K306, 1B176, 8329, 9340, 0327, 9H236, 0C266, 0I166, 0L036, 1B196, 8340, 0301, 0328, 9H246, 0C276, 0I176, 0L046, 1B216, 8341, 0302, 0329, 9H256, 0D076, 0I186, 0L066, 1B226, 8342, 0303, 0330, 0A186, 0D086, 0I206, 0L076, 1B236, 9301, 0304, 0331, 0A196, 0D096,0I256, 0L086, 1C016, 9302, 0305, 0332, 0A206, 0D106, 0I276, 0L096, 1C026, 9304, 0306, 1302, 0A216, 0D126, 0J236, 0L226, 1C036, 9305, 0307, 1303, 0A226, 0E086, 0J256, A196 and 1C046.
• FEI Number: 3007829657
• Recalling Firm/ Manufacturer: Apogee Medical, Inc; 90 Weathers St.; Youngsville NC 27596-7801
• For Additional Information Contact: Diane N. Peper; 919-570-9605 Ext. 224
• Manufacturer Reason for Recall: Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.
• FDA Determined Cause: Other
• Action: The firm, Apogee Medical LLC, sent an "Urgent Medical Device Recall" letter dated March 23, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their inventory; complete and return the enclosed Product Recall Response Form as soon as possible via fax to (919) 570-9611, mail to: Apogee Medical LLC, Youngsville Commerce Center, 90 Weathers Street, Youngsville, MC 27596, or e-mail to: dpeper@apogeemed.com; cease further distribution and return any product that is the subject of this recall to Apogee Medical LLC. All returned product must be labeled with a returned goods authorization label that has been provided with the letter. Apogee will replace returned product upon receipt of the Product Recall Response Form and identified product. In addition, if the customer distributed the product, they are to identify their customer(s) and notify them at once of this product recall. The notification should include a copy of the this recall notification letter and should instruct the customer to return the recalled product so that it can be returned to Apogee. Should you have any questions regarding this notification, please call the Manager Regulatory Affairs/Quality Assurance at (919) 435-5409.
• Quantity in Commerce: 5,503,430 units
• Distribution: Nationwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NJ, NY, OH, OK, TN, TX, VA and WA.
• 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.