Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo endotoxin testing to the proper levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where endotoxin testing was not performed to proper levels, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Ecolab Inc is recalling 2,102 individual units of Microtek Medical Bur Hole Latex Probe Covers, featuring IsoSilk, 5" x 98" (13cm x 249 cm), REF 3688, STERILE EO, QTY 20. The product is manufactured by Microtek Medical, Inc., located in Columbus, MS.
The recall was initiated because certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. The affected lot numbers are 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.
The product was distributed nationwide in the United States and in Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- 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
- Manufacturer
- Ecolab Inc
- Hazard
- Affected units
- 2,102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: D102471
- D102661
- D102701
- D110831
- D111101
- D111151
- D111231
- D111441
- D112301
- D112851
- D112991
- D113551
- D120821
- D121181
- D121951
- D122421
- D130171
- D130381
- D82321
- D82871
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Ecolab Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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