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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Event Detail

Event ID 65667
Product Type Devices
Status Ongoing
Recalling Firm Ecolab Inc
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 6,000 individual units Z-0948-2014
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 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 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 6,040 individual units Z-0947-2014
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 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 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 2,102 individual units Z-0946-2014
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: 126429V, 126602V, 126611V, 126612V, 126613V, 126614V, 127176V, 127182V, 127331V, 127382V, 137533V, 137826V, 137967V, 137666V, 137787V, and 137817V Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 12,546 individual units Z-0945-2014
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702 Lot Numbers: D100131, D100341, D101521, D101861, D101871, D101881, D101891, D101901, D101931, D101941, D101951, D102491, D102531, D102651, D102731, D110691, D110831, D110841, D111021, D111111, D111221, D111381, D111451, D111651, D111801, D111961, D112091, D112231, D112371, D112511, D112661, D112791, D112911, D113061, D113211, D113341, D113481, D120111, D120261, D120401, D120551, D120661, D120811, D120811A, D120941, D121091, D121311, D121371, D121511, D121661, D121681, D122141, D122431, D122561, D122991, D130581, D81701, D81711, D82661, D83041, D83501, D90691, D90701, D91611, D92011, D92021, D92121, D92431, D92601, D92991, D93061, DA100051, DA100061, DA100341, DA100951, DA100971, DA101511, DA101521, DA102011, DA81931, DA82451, DA83011, DA83031, DA83241, DA91131,DA91141, DA91601, and DA92881 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 210, 560 individual units Z-0944-2014
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. 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 Class II Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. 1800 individual units Z-0943-2014
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