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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 GELsee related information
Date Initiated by FirmJuly 02, 2013
Date PostedFebruary 10, 2014
Recall Status1 Terminated 3 on May 14, 2014
Recall NumberZ-0946-2014
Recall Event ID 65667
510(K)NumberK882724 
Product Classification Drape, surgical - Product Code KKX
ProductMICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Code Information Lot Numbers: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671
Recalling Firm/
Manufacturer
Ecolab Inc
370 Wabasha St N
Saint Paul MN 55102
For Additional Information ContactJolly 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
ActionThe 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 Commerce2,102 individual units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = KKX
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