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.
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 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
- 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.
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