Z-0946-2014 Class II Terminated
FDA device recall Z-0946-2014 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: 2,102 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
- 2,102 individual units
Product Description
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
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: 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0946-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026