Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
What this means for you
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 a critical safety test (endotoxin) was not performed to proper levels, creating a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ecolab Inc is recalling 12,546 individual units of Microtek Medical Bur Hole Latex Free Probe Covers with Gel. The affected products are sterile, ethylene oxide (EO) sterilized, and feature IsoSilk. The recall includes 16 specific lot numbers, including 126429V, 126602V, and 137817V.
The recall was initiated because certain lots of these probe covers did not undergo endotoxin (LAL) testing to the proper levels. Endotoxin testing is a standard procedure to ensure that medical devices are free from bacterial contamination that could cause adverse reactions in patients.
The affected products were distributed nationwide in the United States and internationally to countries including Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- 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
- Manufacturer
- Ecolab Inc
- Affected units
- 12,546
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 (16)
- Lot Numbers: 126429V
- 126602V
- 126611V
- 126612V
- 126613V
- 126614V
- 127176V
- 127182V
- 127331V
- 127382V
- 137533V
- 137826V
- 137967V
- 137666V
- 137787V
- and 137817V
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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