3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determ

FDA device recall Z-2002-2014 · posted 2014-07-07 · Terminated

Recall details

Recalling firm

3M Company - Health Care Business

Reason for recall

Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.

Action taken

Consignees were sent on 6/9/2014 a 3M "Urgent Medical Devices Correction" letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.

Root cause

Labeling Change Control

Status

Terminated

Product code

FRC

Quantity affected

5343 (2621 USA, 2722 OUS)

Distribution

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KO

Date initiated

2014-06-09

Date posted

2014-07-07

Date terminated

2015-06-03

Location

Saint Paul, MN

Related 510(k) clearances