Recall Z-2744-2016— Ecolab Inc

Name: FDA recall Z-2744-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Class II · Terminated

Class II FDA medical device recall by Ecolab Inc, initiated 2016-07-14, terminated 2016-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm: Ecolab Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Terminated: 2016-11-02
Firm location: Saint Paul, MN, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.