Home / Recalls / Ecolab Inc / Z-0944-2014

Z-0944-2014 Class II Terminated

Recalled by Ecolab Inc — Saint Paul, MN

FDA device recall Z-0944-2014 was initiated by Ecolab Inc on Jul 2, 2013 and is designated Class II. Reason for recall: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. The recall status is terminated (terminated May 14, 2014). Affected quantity: 210, 560 individual units.

Recall Details

Product Type: Devices
Report Date: Feb 19, 2014
Initiation Date: Jul 2, 2013
Termination Date: May 14, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 210, 560 individual units

Product Description

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

Reason for Recall

Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

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.

Code Information

Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371, D121511, D121661, D121681, D122141, D122431, D122561, D122991, D130581, D81701, D81711, D82661, D83041, D83501, D90691, D90701, D91611, D92011, D92021, D92121, D92431, D92601, D92991, D93061, DA100051, DA100061, DA100341, DA100951, DA100971, DA101511, DA101521, DA102011, DA81931, DA82451, DA83011, DA83031, DA83241, DA91131,DA91141, DA91601, and DA92881

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0944-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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