Recall Z-0946-2014— Ecolab Inc

Name: FDA recall Z-0946-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-02

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: MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702. 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 record

K882724 — MICROTEK PROBE DRAPEMicrobio-Medics, Inc.·cleared 1988-08-03

K-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

MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

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.