Medical device recalls Moderate risk

Ecolab Inc recalls Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Sh…

Recall date
July 14, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2744-2016
FDA classification
Class II
Brand / firm
Ecolab Inc
Sold / distributed
US: OH, NY, CA, MN.

Why it was recalled

Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.

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 Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

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