Class 2 Device Recall BUR HOLE LATEX FREE PROBE COVER

• Date Initiated by Firm: July 02, 2013
• Date Posted: February 10, 2014
• Recall Status: Terminated on May 14, 2014
• Recall Number: Z-0943-2014
• Recall Event ID: 65667
• 510(K)Number: K882724
• Product Classification: Drape, surgical - Product Code KKX
• Product: MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
• Code Information: Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891
• Recalling Firm/ Manufacturer: Ecolab Inc; 370 Wabasha St N; Saint Paul MN 55102
• For Additional Information Contact: Jolly Roman Blahoski; 651-293-4385
• Manufacturer Reason for Recall: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
• FDA Determined Cause: Process design
• Action: The recall was conducted to the consumer/user level. The firm notified their direct consignees of the problem and the recall by written letter mailed on July 2, 2013. The notice requested the consignees to quarantine any recalled product on hand, and complete and return the response form by July 31, 2013. The consignees who further distributed the recalled product were asked to notify their consignees.
• Quantity in Commerce: 1800 individual units
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
• 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 = KKX