PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 19, 2014 Initiated: July 2, 2013 #Z-0948-2014

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Ecolab Inc
Units Affected
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.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
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. Recalled by Ecolab Inc. Units affected: 6,000 individual units.
Why was this product recalled?
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2014. Severity: Moderate. Recall number: Z-0948-2014.