Recall Z-2080-2012— Beekley Corporation

Name: FDA recall Z-2080-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Class II · Terminated

Class II FDA medical device recall by Beekley Corporation, initiated 2012-07-02, terminated 2013-07-09. It names one FDA 510(k) clearance: K073262. Product: Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.. Reason: Imaging artifact can occur on mammogram result.

Recalling firm: Beekley Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Terminated: 2013-07-09
Firm location: Bristol, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K073262 — BELLABeekley Corp.·cleared 2008-03-26

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

Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

Reason for recall

Imaging artifact can occur on mammogram result

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