FDA Device recall Z-0943-2014
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical…
- 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, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical… 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-0943-2014 |
| 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, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, 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: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D1223…Lot Numbers: D100891, D101191, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521, D122361, D81701, D83031, D90231, D90911, D91171, D91821, D92081, D92301, D92601, D92801, D93411, DA82321, DA82451, and DA90891 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2014%22
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