Z-0943-2014 Class II Terminated
FDA device recall Z-0943-2014 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: 1800 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
- 1800 individual units
Product Description
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 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: 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0943-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026