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
This recall has been terminated (originally issued February 10, 2014).
- Company
- Ecolab Inc
- Recall Initiated
- July 2, 2013
- Posted
- February 10, 2014
- Terminated
- May 14, 2014
- Recall Number
- Z-0947-2014
- Quantity
- 6,040 individual units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
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.
Lot / Code Info
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
Root Cause
Process design
Action Taken
The recall was conducted to the consumer/user level. The firm notified their direct consignees of the problem and the recall by written letter mailed on July 2, 2013. The notice requested the consignees to quarantine any recalled product on hand, and complete and return the response form by July 31, 2013. The consignees who further distributed the recalled product were asked to notify their consignees.