Device product
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Z-0947-2014
Product summary
- Firm
- Ecolab Inc
- Event
- Event 65667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,040 individual units
- Official record key
device-enforcement:Z-0947-2014
Official wording
Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Code information: Lot Numbers: D101931, D101981, D102471, D110561, D111801, D112301, D112511, D112991, D113421, D120191, D120651, D121521, D122221, D123401, D130171, D130311, D130431, D82061, D82321, D82871, D83371, DA101891, DA81561, DA82061, and DA85161
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.
Derived failure modes
-
Unknown
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.