Recall Z-0948-2014— Ecolab Inc
Class II · Terminated
Class II FDA medical device recall by Ecolab Inc, initiated 2013-07-02, terminated 2014-05-14. It names one FDA 510(k) clearance: K882724. 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. Reason: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels..
- Recalling firm
- Ecolab Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-02
- Terminated
- 2014-05-14
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.