MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Recall Z-0944-2014 · Posted 2014-02-10
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Recalling FirmEcolab Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2013-07-02
Date Terminated2014-05-14
Product Quantity210, 560 individual units
Reason for Recall
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Firm 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.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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