FDA-Device2016-09-14Class II

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.

Ecolab Inc
Hazard

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.

Sold states
US: OH, NY, CA, MN.
Affected count
6750 eaches (675 cases)
Manufactured in
370 Wabasha St N, Saint Paul, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2016

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