FDA Device recall Z-0944-2014
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 2…
- FDA Device
- Class II
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class II recall of 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 2… by Ecolab, citing certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0944-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-02 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ecolab |
| Distribution | US |
Product
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
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Identifiers
| code_info | Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D10249…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0944-2014%22
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