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.
Reported: February 19, 2014 Initiated: July 2, 2013 #Z-0943-2014
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.
Details
- Recalling Firm
- Ecolab Inc
- Units Affected
- 1800 individual units
- Distribution
- 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.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ecolab Inc. Units affected: 1800 individual units.
Why was this product recalled? ▼
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2014. Severity: Moderate. Recall number: Z-0943-2014.
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