Microtek Medical recalled over sterility concerns

Recall date

August 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ecolab Inc recalls Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-3…

Recall number

Z-2793-2015

FDA classification

Class II

Brand / firm

Ecolab Inc

Sold / distributed

Worldwide Distribution -- US, including DC and PR; and, the countries of SAUDI ARABIA, LEBANON, GERMANY, HONG KONG, SINGAPORE, CANADA, and JAPAN.

Why it was recalled

The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.