Class 2 Device Recall Irrigation Kit

• Date Initiated by Firm: January 18, 2011
• Date Posted: February 03, 2011
• Recall Status: Terminated on February 28, 2012
• Recall Number: Z-1038-2011
• Recall Event ID: 57721
• Product Classification: Lubricant, patient - Product Code KMJ
• Product: Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
• Code Information: Catalog number: 6114, Lot numbers: 11121, 11265, 11417, 11697, 11883, 12274, 12621, 12768, 13006, 13315, 13318, 13549, 13739, 14095, 14947, 15782, 15990, 17017, 17382, 17730, 18476, 18910, 19555, 19759, 20021.
• Recalling Firm/ Manufacturer: Apogee Medical; 90 Hearther Ct; Youngsville NC 27596
• For Additional Information Contact: Diane N. Peper; 919-435-5409
• Manufacturer Reason for Recall: This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.
• FDA Determined Cause: Other
• Action: The firm, TRIAD Group, sent a "Urgent Medical Device Recall" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return the recalled product to the wholesaler who would then return the product to Apogee Medical. Non-responders to the recall notice will be contacted on a weekly basis. Should you have any questions regarding this notification, please call the Regulatory Affairs/Quality Assurance Manager at (919) 435-5409.
• Quantity in Commerce: see line 1.
• Distribution: Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, 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.