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U.S. Department of Health and Human Services

Class 2 Device Recall Irrigation Kit

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  Class 2 Device Recall Irrigation Kit see related information
Date Initiated by Firm January 18, 2011
Date Posted February 03, 2011
Recall Status1 Terminated 3 on February 28, 2012
Recall Number Z-1039-2011
Recall Event ID 57721
Product Classification Lubricant, patient - Product Code KMJ
Product Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.

Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
Code Information Catalog number: 6115, Lot numbers: 11266, 11418, 12116, 12275, 12769, 13158, 13317, 13550, 13738, 14948, 15783, 15991, 16884, 17383, 17958, 18911, 19761.
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 2		 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.
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