FDAClass IIFebruary 19, 2014

Vital Care(tm) Reps Inc. Ultrasound Probe Cover recall: Endotoxin

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.…

Why was Vital Care(tm) Reps Inc. Ultrasound Probe Cover recalled?

Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
Ecolab Inc
Quantity
6,000 individual units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.
Recall date
February 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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