The Recall Desk
HighFDA (Devices)·Z-0948-2014·Announced 2014-02-19

Ecolab Recalls Vital Care Ultrasound Probe Covers Due to Testing Deficiencies

Ecolab Inc is recalling specific lots of Vital Care ultrasound probe covers because they did not undergo endotoxin testing to the proper levels.

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 is classified as FDA Class II. The hazard involves a failure in endotoxin testing for a sterile medical device, which presents a risk of harm, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Ecolab Inc is recalling 6,000 individual units of Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, REF VPC0699. The affected products are sterile, ethylene oxide (EO) sterilized covers manufactured for Vital Care Reps, Inc., located in Tinley Park, Illinois.

The recall was initiated because certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. The specific lot numbers involved in this recall are D111571, D120421, D123471, D83111, DA90721, and DA90961.

The affected units were distributed nationwide in the United States and internationally to Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada. Healthcare facilities and distributors should identify and quarantine the affected lots.

The recalled product

Product
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
Manufacturer
Ecolab Inc
Category
Medical Device — Ultrasound Accessories
Hazard
Affected units
6,000

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 (6)

  • Lot Numbers: D111571
  • D120421
  • D123471
  • D83111
  • DA90721
  • and DA90961

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

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Same hazard · endotoxin

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