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U.S. Department of Health and Human Services

Class 2 Device Recall BUR HOLE LATEX PROBE COVER WITH GEL

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  Class 2 Device Recall BUR HOLE LATEX PROBE COVER WITH GEL see related information
Date Initiated by Firm July 02, 2013
Date Posted February 10, 2014
Recall Status1 Terminated 3 on May 14, 2014
Recall Number Z-0947-2014
Recall Event ID 65667
510(K)Number K882724  
Product Classification Drape, surgical - Product Code KKX
Product MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Code Information Lot Numbers: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161
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 2		 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 6,040 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 and Original Applicant = MICROBIO-MEDICS, INC.
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