The Recall Desk
ModerateFDA (Devices)·Z-0943-2014·Announced 2014-02-19

Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects

Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ecolab Inc is recalling 1,800 individual units of Microtek Medical Bur Hole Latex Free Probe Covers. The affected product is the 13cm x 244 cm (5" x 96") size, reference number PC3688N, sold in quantities of 100.

The recall was initiated because certain lots of these probe covers did not undergo endotoxin (LAL) testing to the proper levels. The affected lot numbers are 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.

The affected units were 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. Consumers and healthcare facilities should check their inventory for these specific lot numbers and contact Ecolab Inc for further instructions.

The recalled product

Product
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.
Manufacturer
Ecolab Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,800

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: D100891
  • D101191
  • D101981
  • D102461
  • D103081
  • D103081A
  • D103331
  • D110871
  • D111021
  • D113551
  • D121521
  • D122361
  • D81701
  • D83031
  • D90231
  • D90911
  • D91171
  • D91821
  • D92081
  • D92301

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Ecolab Inc

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Same hazard · endotoxin contamination

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