Device 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
Z-0948-2014
Product summary
- Firm
- Ecolab Inc
- Event
- Event 65667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,000 individual units
- Official record key
device-enforcement:Z-0948-2014
Official wording
Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Code information: Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961
Distribution pattern: 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.
Derived failure modes
-
Unknown
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.