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Recall Observatory FDA recall evidence

Device product

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Z-0946-2014

July 02, 2013

Class II

Product summary

Firm
Ecolab Inc
Event
Event 65667
Status
Terminated
Classification
Class II
Quantity
2,102 individual units
Official record key
device-enforcement:Z-0946-2014

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: D102471, D102661, D102701, D110831, D111101, D111151, D111231, D111441, D112301, D112851, D112991, D113551, D120821, D121181, D121951, D122421, D130171, D130381, D82321, D82871, D83261, D90261, D91671, DA102491, DA90491, DA90621, DA91061, and DA91671

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

    reason.no_named_rule · v1.0.0

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